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ZEPHYR: Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00084266
Collaborator
(none)
1,225
Enrollment
177
Locations
2
Arms
65
Duration (Months)
6.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Subjects receiving linezolid for the treatment phase of the study

Drug: linezolid (Zyvox)
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Other Names:
  • Zyvox, linezolid

    		•
    Active Comparator: 2

    Subjects receiving vancomycin for the treatment phase of the study

    Drug: vancomycin
    Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population [EOS (7-30 days after last dose)]

      Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.

    Secondary Outcome Measures

    1. Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population [EOS (7-30 days after last dose)]

      Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.

    2. Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population [EOT (within 72 hours of last dose)]

      Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.

    3. Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population [EOT (within 72 hours of last dose)]

      Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.

    4. Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population [EOS (7-30 days after last dose)]

      Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

    5. Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population [EOS (7-30 days after last dose)]

      Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

    6. Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population [EOT (within 72 hours of last dose)]

      Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

    7. Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population [EOT (within 72 hours of last dose)]

      Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

    8. Number of Participants With Clinical Signs and Symptoms at EOS for PP Population [EOS (7-30 days after last dose)]

      Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

    9. Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population [EOS (7-30 days after last dose)]

      Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

    10. Number of Participants With Clinical Signs and Symptoms at EOT for PP Population [EOT (within 72 hours of last dose)]

      Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

    11. Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population [EOT (within 72 hours of last dose)]

      Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

    12. Survival Status Estimated by Kaplan-Meier Analysis for PP Population [From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.]

      For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.

    13. Survival Status Estimated by Kaplan-Meier Analysis for mITT Population [From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.]

      For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.

    14. Survival Status Estimated by Kaplan-Meier Analysis for ITT Population [From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.]

      For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.

    • Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.

    • Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

    Exclusion Criteria:

    • Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).

    • Subjects with severe neutropenia (<500 cells/mm3)

    • Subjects with hypersensitivity to oxazolidinones or vancomycin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Birmingham Alabama United States 35233
    2 Pfizer Investigational Site Birmingham Alabama United States 35249
    3 Pfizer Investigational Site Birmingham Alabama United States 35294
    4 Pfizer Investigational Site Huntsville Alabama United States 35801
    5 Pfizer Investigational Site Montgomery Alabama United States 36106
    6 Pfizer Investigational Site Montgomery Alabama United States 36111
    7 Pfizer Investigational Site Phoenix Arizona United States 85013
    8 Pfizer Investigational Site Los Angeles California United States 90033
    9 Pfizer Investigational Site Orange California United States 92868
    10 Pfizer Investigational Site Redlands California United States 92373
    11 Pfizer Investigational Site Sacramento California United States 95817
    12 Pfizer Investigational Site San Diego California United States 92120
    13 Pfizer Investigational Site San Diego California United States 92123
    14 Pfizer Investigational Site San Francisco California United States 94110
    15 Pfizer Investigational Site Denver Colorado United States 80204
    16 Pfizer Investigational Site Denver Colorado United States 80205
    17 Pfizer Investigational Site Denver Colorado United States 80218
    18 Pfizer Investigational Site Newark Delaware United States 19718
    19 Pfizer Investigational Site Washington District of Columbia United States 20017
    20 Pfizer Investigational Site Washington District of Columbia United States 20037
    21 Pfizer Investigational Site Brandon Florida United States 33511
    22 Pfizer Investigational Site Fort Lauderdale Florida United States 33316
    23 Pfizer Investigational Site Gainesville Florida United States 32610
    24 Pfizer Investigational Site Jacksonville Florida United States 32209
    25 Pfizer Investigational Site Jackson Florida United States 32209
    26 Pfizer Investigational Site Miami Florida United States 33136
    27 Pfizer Investigational Site Orlando Florida United States 32801
    28 Pfizer Investigational Site Orlando Florida United States 32806
    29 Pfizer Investigational Site Tampa Florida United States 33607
    30 Pfizer Investigational Site Augusta Georgia United States 30909
    31 Pfizer Investigational Site Augusta Georgia United States 30912
    32 Pfizer Investigational Site Decatur Georgia United States 30030
    33 Pfizer Investigational Site Decatur Georgia United States 30033
    34 Pfizer Investigational Site Honolulu Hawaii United States 96817
    35 Pfizer Investigational Site Chicago Illinois United States 60612
    36 Pfizer Investigational Site North Chicago Illinois United States 60064
    37 Pfizer Investigational Site Oak Park Illinois United States 60302-2566
    38 Pfizer Investigational Site Springfield Illinois United States 62701
    39 Pfizer Investigational Site Springfield Illinois United States 62702
    40 Pfizer Investigational Site Springfield Illinois United States 62703
    41 Pfizer Investigational Site New Albany Indiana United States 47151
    42 Pfizer Investigational Site Hazard Kentucky United States 41701
    43 Pfizer Investigational Site Lexington Kentucky United States 40536
    44 Pfizer Investigational Site Louisville Kentucky United States 40202
    45 Pfizer Investigational Site Louisville Kentucky United States 40206
    46 Pfizer Investigational Site Baltimore Maryland United States 21201
    47 Pfizer Investigational Site Boston Massachusetts United States 02111
    48 Pfizer Investigational Site Boston Massachusetts United States 02114
    49 Pfizer Investigational Site Boston Massachusetts United States 02115
    50 Pfizer Investigational Site Boston Massachusetts United States 02118
    51 Pfizer Investigational Site Springfield Massachusetts United States 01199
    52 Pfizer Investigational Site Ann Arbor Michigan United States 48109-0331
    53 Pfizer Investigational Site Detroit Michigan United States 48201
    54 Pfizer Investigational Site Detroit Michigan United States 48202
    55 Pfizer Investigational Site Detroit Michigan United States 48210
    56 Pfizer Investigational Site Saint Louis Missouri United States 63110-1010
    57 Pfizer Investigational Site St. Loius Missouri United States 63110
    58 Pfizer Investigational Site St. Louis Missouri United States 63110
    59 Pfizer Investigational Site Omaha Nebraska United States 68131
    60 Pfizer Investigational Site Las Vegas Nevada United States 89109
    61 Pfizer Investigational Site Reno Nevada United States 89502
    62 Pfizer Investigational Site Reno Nevada United States 89503
    63 Pfizer Investigational Site Hackensack New Jersey United States 07601
    64 Pfizer Investigational Site Albany New York United States 12208
    65 Pfizer Investigational Site Bronx New York United States 10457
    66 Pfizer Investigational Site Brooklyn New York United States 11215
    67 Pfizer Investigational Site Buffalo New York United States 14215
    68 Pfizer Investigational Site New York New York United States 10011
    69 Pfizer Investigational Site New York New York United States 10021-9800
    70 Pfizer Investigational Site New York New York United States 10029
    71 Pfizer Investigational Site Rochester New York United States 14642-8410
    72 Pfizer Investigational Site Rochester New York United States 14642
    73 Pfizer Investigational Site Greensboro North Carolina United States 27401
    74 Pfizer Investigational Site Fargo North Dakota United States 58112
    75 Pfizer Investigational Site Fargo North Dakota United States 58122
    76 Pfizer Investigational Site Cincinnati Ohio United States 45219
    77 Pfizer Investigational Site Cincinnati Ohio United States 45267-0558
    78 Pfizer Investigational Site Columbus Ohio United States 43210
    79 Pfizer Investigational Site Columbus Ohio United States 43214
    80 Pfizer Investigational Site Columbus Ohio United States 43215
    81 Pfizer Investigational Site Columbus Ohio United States 43222
    82 Pfizer Investigational Site Sylvania Ohio United States 43560
    83 Pfizer Investigational Site Toledo Ohio United States 43608
    84 Pfizer Investigational Site Toledo Ohio United States 43614
    85 Pfizer Investigational Site Portland Oregon United States 97213
    86 Pfizer Investigational Site Portland Oregon United States 97220
    87 Pfizer Investigational Site Abington Pennsylvania United States 19001
    88 Pfizer Investigational Site Allentown Pennsylvania United States 18103
    89 Pfizer Investigational Site Bethlehem Pennsylvania United States 18017
    90 Pfizer Investigational Site Philadelphia Pennsylvania United States 19102
    91 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15213
    92 Pfizer Investigational Site Providence Rhode Island United States 02903
    93 Pfizer Investigational Site Charleston South Carolina United States 29425
    94 Pfizer Investigational Site Sioux Falls South Dakota United States 57104
    95 Pfizer Investigational Site Sioux Falls South Dakota United States 57105
    96 Pfizer Investigational Site Sioux Falls South Dakota United States 57117-5045
    97 Pfizer Investigational Site Nashville Tennessee United States 37232-7110
    98 Pfizer Investigational Site Nashville Tennessee United States 37232
    99 Pfizer Investigational Site Houston Texas United States 77030-1608
    100 Pfizer Investigational Site Irving Texas United States 75061
    101 Pfizer Investigational Site San Antonio Texas United States 78229
    102 Pfizer Investigational Site San Antonio Texas United States 78284
    103 Pfizer Investigational Site San Marcos Texas United States 78666
    104 Pfizer Investigational Site Sequin Texas United States 78155
    105 Pfizer Investigational Site Temple Texas United States 76508
    106 Pfizer Investigational Site Murray Utah United States 84157
    107 Pfizer Investigational Site Richmond Virginia United States 23219
    108 Pfizer Investigational Site Winchester Virginia United States 22601
    109 Pfizer Investigational Site Buenos Aires Argentina 1181
    110 Pfizer Investigational Site Brugge Belgium 8000
    111 Pfizer Investigational Site Brussels Belgium 1070
    112 Pfizer Investigational Site Gent Belgium 9000
    113 Pfizer Investigational Site Liege 1 Belgium B-4000
    114 Pfizer Investigational Site Salvador BA Brazil 40420-000
    115 Pfizer Investigational Site Sao Jose do Rio Preto SP Brazil 15090-000
    116 Pfizer Investigational Site São Paulo SP Brazil 05651-901
    117 Pfizer Investigational Site Santiago Región Metropolitana Chile
    118 Pfizer Investigational Site Santiago RM Chile
    119 Pfizer Investigational Site Santiago Chile
    120 Pfizer Investigational Site Barranquilla Atlantico Colombia
    121 Pfizer Investigational Site Bogota Bogota. DC Colombia
    122 Pfizer Investigational Site Bogota Cundinamarca Colombia
    123 Pfizer Investigational Site Ibague Tolima Colombia
    124 Pfizer Investigational Site Paris Cedex 18 France 75877
    125 Pfizer Investigational Site Marseille Cedex 20 France 13915
    126 Pfizer Investigational Site Paris France 75013
    127 Pfizer Investigational Site Saint Etienne Cedex 02 France 42055
    128 Pfizer Investigational Site Goettingen Germany 37075
    129 Pfizer Investigational Site Leipzig Germany 04129
    130 Pfizer Investigational Site Leipzig Germany 04289
    131 Pfizer Investigational Site Kifisia Athens Greece 14561
    132 Pfizer Investigational Site Athens Greece 10676
    133 Pfizer Investigational Site Crete Greece 71110
    134 Pfizer Investigational Site Thessaloniki Greece 57010
    135 Pfizer Investigational Site Hong Kong Hong Kong
    136 Pfizer Investigational Site Seoul Korea, Republic of 134-701
    137 Pfizer Investigational Site Seoul Korea, Republic of 135-710
    138 Pfizer Investigational Site Seoul Korea, Republic of 136-705
    139 Pfizer Investigational Site Seoul Korea, Republic of 138-736
    140 Pfizer Investigational Site Seoul Korea, Republic of 150-713
    141 Pfizer Investigational Site Kuala Lumpur Malaysia 50586
    142 Pfizer Investigational Site Kuala Lumpur Malaysia 59100
    143 Pfizer Investigational Site Mexico DF Mexico 14000
    144 Pfizer Investigational Site Guadalajara Jalisco Mexico 44280
    145 Pfizer Investigational Site Monterrey/Col. Mitras Centro Nuevo Léon Mexico 64460
    146 Pfizer Investigational Site Ciudad Madero Tamaulipas Mexico 89440
    147 Pfizer Investigational Site Bytom Poland 41-902
    148 Pfizer Investigational Site Katowice Poland 40-752
    149 Pfizer Investigational Site Krakow Poland 31 - 066
    150 Pfizer Investigational Site Krakow Poland 31-066
    151 Pfizer Investigational Site Almada Portugal 2800
    152 Pfizer Investigational Site Coimbra Portugal 3041
    153 Pfizer Investigational Site Lisboa Portugal 1449-005
    154 Pfizer Investigational Site Senhora da Hora Portugal 4464-513
    155 Pfizer Investigational Site Ponce Puerto Rico 00716
    156 Pfizer Investigational Site San Juan Puerto Rico 00921-3201
    157 Pfizer Investigational Site Moscow Russia Russian Federation 117049
    158 Pfizer Investigational Site Moscow Russian Federation 111539
    159 Pfizer Investigational Site Moscow Russian Federation 113093
    160 Pfizer Investigational Site Moscow Russian Federation 115446
    161 Pfizer Investigational Site Moscow Russian Federation 115478
    162 Pfizer Investigational Site Moscow Russian Federation 123448
    163 Pfizer Investigational Site Auckland Park South Africa 2006
    164 Pfizer Investigational Site Bloefontein South Africa 9301
    165 Pfizer Investigational Site Soweto South Africa 2013
    166 Pfizer Investigational Site Badalona Barcelona Spain 08916
    167 Pfizer Investigational Site Barcelona Spain 08003
    168 Pfizer Investigational Site Barcelona Spain 08036
    169 Pfizer Investigational Site Madrid Spain 28040
    170 Pfizer Investigational Site Kaohsiung Taiwan 813
    171 Pfizer Investigational Site Pan-Chiao Taiwan 220
    172 Pfizer Investigational Site Taichung Taiwan 404
    173 Pfizer Investigational Site Taipei Taiwan 100
    174 Pfizer Investigational Site Ankara Turkey 06100
    175 Pfizer Investigational Site Plymouth Devon United Kingdom PL6 8DH
    176 Pfizer Investigational Site Edinburgh United Kingdom EH16 4SA
    177 Pfizer Investigational Site

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00084266
    Other Study ID Numbers:
    • A5951001
    First Posted:
    Jun 11, 2004
    Last Update Posted:
    Feb 1, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Pfizer
    Staphylococcal pneumonia
    Methicillin-resistant staphylococcal pneumonia
    healthcare-associated pneumonia
    Additional relevant MeSH terms:
    Pneumonia
    Staphylococcal Infections
    Healthcare-Associated Pneumonia
    Vancomycin
    Linezolid

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Period Title: Overall Study
    STARTED 618 607
    Treated 597 587
    COMPLETED 177 184
    NOT COMPLETED 441 423

    Baseline Characteristics

    Arm/Group Title Linezolid Vancomycin Total
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Total of all reporting groups
    Overall Participants 597 587 1184
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    60.5
    (18.4)
    60.5
    (18.4)
    60.5
    (18.4)
    Sex: Female, Male (Count of Participants)
    Female
    202
    33.8%
    207
    35.3%
    409
    34.5%
    Male
    395
    66.2%
    380
    64.7%
    775
    65.5%
    Clinical Signs and Symptoms for modified intent-to-treat (mITT) Population (Number) [Number]
    Decreased Breath Sounds
    169
    28.3%
    182
    31%
    351
    29.6%
    Hypoxia
    164
    27.5%
    151
    25.7%
    315
    26.6%
    Pulmonary Consolidation
    173
    29%
    184
    31.3%
    357
    30.2%
    Rales
    172
    28.8%
    177
    30.2%
    349
    29.5%
    Tachypnea
    152
    25.5%
    143
    24.4%
    295
    24.9%
    Chills/Rigors
    22
    3.7%
    11
    1.9%
    33
    2.8%
    Cough
    122
    20.4%
    107
    18.2%
    229
    19.3%
    Dyspnea
    99
    16.6%
    95
    16.2%
    194
    16.4%
    Pleuritic Chest Pain
    14
    2.3%
    12
    2%
    26
    2.2%
    Purulent Sputum
    167
    28%
    209
    35.6%
    376
    31.8%
    Clinical Signs and Symptoms for Per Protocol (PP) Population (Number) [Number]
    Decreased Breath Sounds
    138
    23.1%
    155
    26.4%
    293
    24.7%
    Hypoxia
    133
    22.3%
    127
    21.6%
    260
    22%
    Pulmonary Consolidation
    145
    24.3%
    158
    26.9%
    303
    25.6%
    Rales
    142
    23.8%
    149
    25.4%
    291
    24.6%
    Tachypnea
    124
    20.8%
    123
    21%
    247
    20.9%
    Chills/Rigors
    18
    3%
    9
    1.5%
    27
    2.3%
    Cough
    101
    16.9%
    90
    15.3%
    191
    16.1%
    Dyspnea
    80
    13.4%
    80
    13.6%
    160
    13.5%
    Pleuritic Chest Pain
    12
    2%
    9
    1.5%
    21
    1.8%
    Purulent Sputum
    171
    28.6%
    174
    29.6%
    345
    29.1%

    Outcome Measures

    1. Primary Outcome
    Title Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
    Description Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
    Time Frame EOS (7-30 days after last dose)

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 165 174
    Cure
    95
    15.9%
    81
    13.8%
    Failure
    70
    11.7%
    93
    15.8%
    Unknown/Missing (excluded from analysis)
    7
    1.2%
    2
    0.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
    Comments Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as "cure".
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments The final p-value was compared against an O'Brien-Fleming boundary of 0.048.
    Statistical Test of Hypothesis p-Value 0.042
    Comments
    Method Chi-squared
    Comments
    2. Secondary Outcome
    Title Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population
    Description Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
    Time Frame EOS (7-30 days after last dose)

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 186 205
    Cure
    102
    17.1%
    92
    15.7%
    Failure
    84
    14.1%
    113
    19.3%
    Unknown/Missing (excluded from analysis)
    38
    6.4%
    19
    3.2%
    3. Secondary Outcome
    Title Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
    Description Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
    Time Frame EOT (within 72 hours of last dose)

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 180 186
    Cure
    76
    12.7%
    70
    11.9%
    Improvement
    74
    12.4%
    60
    10.2%
    Failure
    30
    5%
    56
    9.5%
    Unknown/Missing (excluded from analysis)
    3
    0.5%
    2
    0.3%
    4. Secondary Outcome
    Title Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
    Description Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
    Time Frame EOT (within 72 hours of last dose)

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 201 214
    Cure
    81
    13.6%
    77
    13.1%
    Improvement
    80
    13.4%
    68
    11.6%
    Failure
    40
    6.7%
    69
    11.8%
    Unknown/Missing (excluded from analysis)
    23
    3.9%
    10
    1.7%
    5. Secondary Outcome
    Title Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
    Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
    Time Frame EOS (7-30 days after last dose)

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 167 174
    MRSA Eradication
    35
    5.9%
    26
    4.4%
    Presumed MRSA Eradication
    62
    10.4%
    56
    9.5%
    MRSA Persistence
    7
    1.2%
    15
    2.6%
    MRSA Recurrence
    15
    2.5%
    11
    1.9%
    Presumed MRSA Persistence
    48
    8%
    66
    11.2%
    Missing/Indeterminate (excluded from analysis)
    5
    0.8%
    2
    0.3%
    6. Secondary Outcome
    Title Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
    Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
    Time Frame EOS (7-30 days after last dose)

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 195 209
    MRSA Eradication
    46
    7.7%
    35
    6%
    Presumed MRSA Eradication
    65
    10.9%
    61
    10.4%
    MRSA Persistence
    9
    1.5%
    22
    3.7%
    MRSA Recurrence
    16
    2.7%
    12
    2%
    Presumed MRSA Persistence
    59
    9.9%
    79
    13.5%
    Missing/Indeterminate (excluded from analysis)
    29
    4.9%
    15
    2.6%
    7. Secondary Outcome
    Title Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
    Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
    Time Frame EOT (within 72 hours of last dose)

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 182 188
    MRSA Eradication
    76
    12.7%
    59
    10.1%
    Presumed MRSA Eradication
    73
    12.2%
    55
    9.4%
    MRSA Persistence
    16
    2.7%
    50
    8.5%
    Presumed MRSA Persistence
    17
    2.8%
    24
    4.1%
    Missing/Indeterminate (excluded from analysis)
    1
    0.2%
    0
    0%
    8. Secondary Outcome
    Title Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
    Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
    Time Frame EOT (within 72 hours of last dose)

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 203 218
    MRSA Eradication
    84
    14.1%
    65
    11.1%
    Presumed MRSA Eradication
    77
    12.9%
    62
    10.6%
    MRSA Persistence
    19
    3.2%
    60
    10.2%
    Presumed MRSA Persistence
    23
    3.9%
    31
    5.3%
    Missing/Indeterminate (excluded from analysis)
    21
    3.5%
    6
    1%
    9. Secondary Outcome
    Title Number of Participants With Clinical Signs and Symptoms at EOS for PP Population
    Description Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
    Time Frame EOS (7-30 days after last dose)

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 172 176
    Decreased Breath Sounds
    42
    7%
    46
    7.8%
    Hypoxia
    30
    5%
    29
    4.9%
    Pulmonary Consolidation
    22
    3.7%
    19
    3.2%
    Rales
    27
    4.5%
    27
    4.6%
    Tachypnea
    39
    6.5%
    36
    6.1%
    Chills/Rigors
    3
    0.5%
    1
    0.2%
    Cough
    32
    5.4%
    33
    5.6%
    Dyspnea
    15
    2.5%
    19
    3.2%
    Pleuritic Chest Pain
    5
    0.8%
    5
    0.9%
    Purulent Sputum
    36
    6%
    26
    4.4%
    10. Secondary Outcome
    Title Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population
    Description Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
    Time Frame EOS (7-30 days after last dose)

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 224 224
    Decreased Breath Sounds
    53
    8.9%
    58
    9.9%
    Hypoxia
    38
    6.4%
    38
    6.5%
    Pulmonary Consolidation
    32
    5.4%
    27
    4.6%
    Rales
    36
    6%
    34
    5.8%
    Tachypnea
    49
    8.2%
    42
    7.2%
    Chills/Rigors
    4
    0.7%
    2
    0.3%
    Cough
    37
    6.2%
    40
    6.8%
    Dyspnea
    19
    3.2%
    23
    3.9%
    Pleuritic Chest Pain
    7
    1.2%
    6
    1%
    Purulent Sputum
    48
    8%
    38
    6.5%
    11. Secondary Outcome
    Title Number of Participants With Clinical Signs and Symptoms at EOT for PP Population
    Description Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
    Time Frame EOT (within 72 hours of last dose)

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 183 188
    Decreased Breath Sounds
    63
    10.6%
    99
    16.9%
    Hypoxia
    56
    9.4%
    60
    10.2%
    Pulmonary Consolidation
    43
    7.2%
    69
    11.8%
    Rales
    49
    8.2%
    61
    10.4%
    Tachypnea
    67
    11.2%
    58
    9.9%
    Chills/Rigors
    3
    0.5%
    0
    0%
    Cough
    53
    8.9%
    59
    10.1%
    Dyspnea
    24
    4%
    27
    4.6%
    Pleuritic Chest Pain
    2
    0.3%
    1
    0.2%
    Purulent Sputum
    55
    9.2%
    74
    12.6%
    12. Secondary Outcome
    Title Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population
    Description Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
    Time Frame EOT (within 72 hours of last dose)

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 224 224
    Decreased Breath Sounds
    73
    12.2%
    109
    18.6%
    Hypoxia
    67
    11.2%
    73
    12.4%
    Pulmonary Consolidation
    53
    8.9%
    77
    13.1%
    Rales
    57
    9.5%
    73
    12.4%
    Tachypnea
    76
    12.7%
    66
    11.2%
    Chills/Rigors
    5
    0.8%
    2
    0.3%
    Cough
    64
    10.7%
    64
    10.9%
    Dyspnea
    28
    4.7%
    33
    5.6%
    Pleuritic Chest Pain
    4
    0.7%
    2
    0.3%
    Purulent Sputum
    67
    11.2%
    85
    14.5%
    13. Secondary Outcome
    Title Survival Status Estimated by Kaplan-Meier Analysis for PP Population
    Description For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
    Time Frame From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

    Outcome Measure Data

    Analysis Population Description
    PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 183 188
    Mean (Standard Error) [Days]
    59.196
    (1.684)
    57.191
    (1.686)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
    Comments Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9344
    Comments
    Method Log Rank
    Comments
    14. Secondary Outcome
    Title Survival Status Estimated by Kaplan-Meier Analysis for mITT Population
    Description For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
    Time Frame From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

    Outcome Measure Data

    Analysis Population Description
    mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 224 224
    Median (Standard Error) [Days]
    58.185
    (1.605)
    57.072
    (1.570)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
    Comments Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5985
    Comments
    Method Log Rank
    Comments
    15. Secondary Outcome
    Title Survival Status Estimated by Kaplan-Meier Analysis for ITT Population
    Description For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
    Time Frame From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of study medication.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Measure Participants 597 587
    Mean (Standard Error) [Days]
    55.590
    (1.511)
    55.369
    (1.484)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
    Comments Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8590
    Comments
    Method Log Rank
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Arm/Group Title Linezolid Vancomycin
    Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    All Cause Mortality
    Linezolid Vancomycin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Linezolid Vancomycin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 145/597 (24.3%) 141/587 (24%)
    Blood and lymphatic system disorders
    Anaemia 0/597 (0%) 2/587 (0.3%)
    Disseminated intravascular coagulation 1/597 (0.2%) 0/587 (0%)
    Haemorrhagic anaemia 2/597 (0.3%) 0/587 (0%)
    Neutropenia 0/597 (0%) 1/587 (0.2%)
    Thrombocytopenia 1/597 (0.2%) 1/587 (0.2%)
    Thrombotic thrombocytopenic purpura 0/597 (0%) 1/587 (0.2%)
    Cardiac disorders
    Acute myocardial infarction 0/597 (0%) 2/587 (0.3%)
    Atrial fibrillation 2/597 (0.3%) 3/587 (0.5%)
    Bradyarrhythmia 0/597 (0%) 1/587 (0.2%)
    Bradycardia 1/597 (0.2%) 2/587 (0.3%)
    Cardiac arrest 11/597 (1.8%) 13/587 (2.2%)
    Cardiac failure congestive 1/597 (0.2%) 5/587 (0.9%)
    Cardiac tamponade 0/597 (0%) 1/587 (0.2%)
    Cardio-respiratory arrest 9/597 (1.5%) 4/587 (0.7%)
    Cardiogenic shock 2/597 (0.3%) 0/587 (0%)
    Cardiomyopathy 1/597 (0.2%) 0/587 (0%)
    Cardiopulmonary failure 1/597 (0.2%) 1/587 (0.2%)
    Coronary artery disease 1/597 (0.2%) 1/587 (0.2%)
    Electromechanical dissociation 2/597 (0.3%) 0/587 (0%)
    Myocardial infarction 3/597 (0.5%) 0/587 (0%)
    Myocardial ischaemia 1/597 (0.2%) 0/587 (0%)
    Pericardial effusion 1/597 (0.2%) 0/587 (0%)
    Pericarditis 1/597 (0.2%) 0/587 (0%)
    Supraventricular tachycardia 0/597 (0%) 1/587 (0.2%)
    Tachycardia 1/597 (0.2%) 1/587 (0.2%)
    Gastrointestinal disorders
    Abdominal pain 1/597 (0.2%) 1/587 (0.2%)
    Ascites 0/597 (0%) 2/587 (0.3%)
    Diarrhoea 0/597 (0%) 1/587 (0.2%)
    Diverticular perforation 1/597 (0.2%) 0/587 (0%)
    Diverticulum intestinal haemorrhagic 1/597 (0.2%) 0/587 (0%)
    Enterocutaneous fistula 0/597 (0%) 1/587 (0.2%)
    Gastric ulcer haemorrhage 1/597 (0.2%) 0/587 (0%)
    Gastrointestinal haemorrhage 1/597 (0.2%) 1/587 (0.2%)
    Gastrointestinal necrosis 0/597 (0%) 1/587 (0.2%)
    Ileus 0/597 (0%) 1/587 (0.2%)
    Intestinal dilatation 1/597 (0.2%) 0/587 (0%)
    Intestinal ischaemia 2/597 (0.3%) 0/587 (0%)
    Intestinal perforation 1/597 (0.2%) 0/587 (0%)
    Large intestine perforation 1/597 (0.2%) 1/587 (0.2%)
    Lower gastrointestinal haemorrhage 1/597 (0.2%) 0/587 (0%)
    Mesenteric vein thrombosis 1/597 (0.2%) 0/587 (0%)
    Nausea 0/597 (0%) 1/587 (0.2%)
    Oesophageal achalasia 1/597 (0.2%) 0/587 (0%)
    Oesophageal varices haemorrhage 0/597 (0%) 1/587 (0.2%)
    Pancreatitis 2/597 (0.3%) 0/587 (0%)
    Peritonitis 1/597 (0.2%) 2/587 (0.3%)
    Small intestinal perforation 1/597 (0.2%) 0/587 (0%)
    Upper gastrointestinal haemorrhage 1/597 (0.2%) 2/587 (0.3%)
    Vomiting 0/597 (0%) 1/587 (0.2%)
    General disorders
    Drug ineffective 1/597 (0.2%) 0/587 (0%)
    Multi-organ disorder 0/597 (0%) 1/587 (0.2%)
    Multi-organ failure 7/597 (1.2%) 3/587 (0.5%)
    Pyrexia 2/597 (0.3%) 0/587 (0%)
    Secretion discharge 1/597 (0.2%) 0/587 (0%)
    Hepatobiliary disorders
    Cholecystitis 2/597 (0.3%) 0/587 (0%)
    Cholecystitis acute 1/597 (0.2%) 0/587 (0%)
    Hepatic cirrhosis 0/597 (0%) 1/587 (0.2%)
    Ischaemic hepatitis 1/597 (0.2%) 0/587 (0%)
    Liver disorder 1/597 (0.2%) 0/587 (0%)
    Immune system disorders
    Hypersensitivity 0/597 (0%) 1/587 (0.2%)
    Infections and infestations
    Abdominal abscess 1/597 (0.2%) 0/587 (0%)
    Abdominal infection 0/597 (0%) 1/587 (0.2%)
    Abdominal sepsis 0/597 (0%) 1/587 (0.2%)
    Abscess intestinal 0/597 (0%) 1/587 (0.2%)
    Acinetobacter bacteraemia 0/597 (0%) 1/587 (0.2%)
    Acinetobacter infection 0/597 (0%) 1/587 (0.2%)
    Bacterial sepsis 1/597 (0.2%) 1/587 (0.2%)
    Candidiasis 0/597 (0%) 1/587 (0.2%)
    Cellulitis 1/597 (0.2%) 0/587 (0%)
    Clostridial infection 0/597 (0%) 1/587 (0.2%)
    Clostridium colitis 1/597 (0.2%) 0/587 (0%)
    Clostridium difficile colitis 1/597 (0.2%) 0/587 (0%)
    Device related infection 0/597 (0%) 1/587 (0.2%)
    Diverticulitis 0/597 (0%) 1/587 (0.2%)
    Endocarditis 1/597 (0.2%) 0/587 (0%)
    Fungal sepsis 0/597 (0%) 1/587 (0.2%)
    Gangrene 1/597 (0.2%) 0/587 (0%)
    Kidney infection 1/597 (0.2%) 0/587 (0%)
    Lung infection pseudomonal 1/597 (0.2%) 2/587 (0.3%)
    Meningitis bacterial 1/597 (0.2%) 0/587 (0%)
    Muscle abscess 1/597 (0.2%) 0/587 (0%)
    Parotitis 0/597 (0%) 1/587 (0.2%)
    Pneumonia 14/597 (2.3%) 9/587 (1.5%)
    Pneumonia bacterial 1/597 (0.2%) 3/587 (0.5%)
    Pneumonia klebsiella 2/597 (0.3%) 0/587 (0%)
    Pneumonia staphylococcal 1/597 (0.2%) 3/587 (0.5%)
    Post procedural sepsis 1/597 (0.2%) 0/587 (0%)
    Postoperative abscess 1/597 (0.2%) 0/587 (0%)
    Postoperative wound infection 1/597 (0.2%) 1/587 (0.2%)
    Pseudomonal bacteraemia 1/597 (0.2%) 0/587 (0%)
    Pseudomonas infection 0/597 (0%) 1/587 (0.2%)
    Pyothorax 0/597 (0%) 1/587 (0.2%)
    Sepsis 9/597 (1.5%) 19/587 (3.2%)
    Septic shock 9/597 (1.5%) 16/587 (2.7%)
    Staphylococcal infection 0/597 (0%) 1/587 (0.2%)
    Staphylococcal sepsis 2/597 (0.3%) 0/587 (0%)
    Systemic candida 1/597 (0.2%) 2/587 (0.3%)
    Toxic shock syndrome streptococcal 0/597 (0%) 1/587 (0.2%)
    Tracheobronchitis 0/597 (0%) 1/587 (0.2%)
    Urinary tract infection 1/597 (0.2%) 1/587 (0.2%)
    Wound infection staphylococcal 1/597 (0.2%) 0/587 (0%)
    Injury, poisoning and procedural complications
    Anastomotic complication 0/597 (0%) 1/587 (0.2%)
    Brain herniation 1/597 (0.2%) 0/587 (0%)
    Failure to anastomose 1/597 (0.2%) 0/587 (0%)
    Fall 1/597 (0.2%) 0/587 (0%)
    Gastrointestinal stoma complication 0/597 (0%) 1/587 (0.2%)
    Pneumothorax traumatic 0/597 (0%) 1/587 (0.2%)
    Post procedural fistula 1/597 (0.2%) 1/587 (0.2%)
    Postoperative ileus 1/597 (0.2%) 0/587 (0%)
    Seroma 1/597 (0.2%) 1/587 (0.2%)
    Tracheal obstruction 0/597 (0%) 1/587 (0.2%)
    Tracheostomy malfunction 0/597 (0%) 1/587 (0.2%)
    Wound dehiscence 1/597 (0.2%) 1/587 (0.2%)
    Wound evisceration 0/597 (0%) 1/587 (0.2%)
    Metabolism and nutrition disorders
    Dehydration 0/597 (0%) 1/587 (0.2%)
    Hyperkalaemia 0/597 (0%) 1/587 (0.2%)
    Hypoglycaemia 0/597 (0%) 1/587 (0.2%)
    Musculoskeletal and connective tissue disorders
    Bursitis 1/597 (0.2%) 0/587 (0%)
    Fistula 0/597 (0%) 1/587 (0.2%)
    Osteonecrosis 1/597 (0.2%) 0/587 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Central nervous system lymphoma 1/597 (0.2%) 0/587 (0%)
    Neuroendocrine carcinoma 1/597 (0.2%) 0/587 (0%)
    Squamous cell carcinoma 0/597 (0%) 1/587 (0.2%)
    Ureteric cancer metastatic 1/597 (0.2%) 0/587 (0%)
    Nervous system disorders
    Brain compression 1/597 (0.2%) 0/587 (0%)
    Brain oedema 3/597 (0.5%) 0/587 (0%)
    Cerebral ischaemia 0/597 (0%) 1/587 (0.2%)
    Cerebrovascular accident 2/597 (0.3%) 3/587 (0.5%)
    Coma 0/597 (0%) 1/587 (0.2%)
    Convulsion 1/597 (0.2%) 1/587 (0.2%)
    Depressed level of consciousness 1/597 (0.2%) 0/587 (0%)
    Haemorrhage intracranial 1/597 (0.2%) 2/587 (0.3%)
    Haemorrhagic stroke 0/597 (0%) 1/587 (0.2%)
    Headache 0/597 (0%) 1/587 (0.2%)
    Hydrocephalus 1/597 (0.2%) 0/587 (0%)
    Hypoxic-ischaemic encephalopathy 0/597 (0%) 2/587 (0.3%)
    Ischaemic stroke 1/597 (0.2%) 2/587 (0.3%)
    Mental impairment 1/597 (0.2%) 0/587 (0%)
    Nervous system disorder 0/597 (0%) 1/587 (0.2%)
    Neurological decompensation 0/597 (0%) 1/587 (0.2%)
    Pneumocephalus 1/597 (0.2%) 0/587 (0%)
    Polyneuropathy 0/597 (0%) 1/587 (0.2%)
    Subarachnoid haemorrhage 0/597 (0%) 1/587 (0.2%)
    Subdural hygroma 0/597 (0%) 1/587 (0.2%)
    Unresponsive to stimuli 1/597 (0.2%) 0/587 (0%)
    Psychiatric disorders
    Mental status changes 0/597 (0%) 3/587 (0.5%)
    Renal and urinary disorders
    Azotaemia 0/597 (0%) 1/587 (0.2%)
    Renal failure 2/597 (0.3%) 6/587 (1%)
    Renal failure acute 5/597 (0.8%) 11/587 (1.9%)
    Renal failure chronic 1/597 (0.2%) 0/587 (0%)
    Renal impairment 3/597 (0.5%) 1/587 (0.2%)
    Urinary retention 1/597 (0.2%) 0/587 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acquired tracheo-oesophageal fistula 1/597 (0.2%) 0/587 (0%)
    Acute respiratory distress syndrome 3/597 (0.5%) 1/587 (0.2%)
    Acute respiratory failure 1/597 (0.2%) 1/587 (0.2%)
    Apnoea 0/597 (0%) 1/587 (0.2%)
    Asphyxia 1/597 (0.2%) 0/587 (0%)
    Aspiration 0/597 (0%) 1/587 (0.2%)
    Atelectasis 1/597 (0.2%) 0/587 (0%)
    Brain hypoxia 1/597 (0.2%) 0/587 (0%)
    Bronchial secretion retention 1/597 (0.2%) 1/587 (0.2%)
    Bronchospasm 1/597 (0.2%) 0/587 (0%)
    Chronic obstructive pulmonary disease 2/597 (0.3%) 0/587 (0%)
    Dependence on respirator 0/597 (0%) 1/587 (0.2%)
    Epistaxis 2/597 (0.3%) 0/587 (0%)
    Haemoptysis 0/597 (0%) 2/587 (0.3%)
    Hypoventilation 1/597 (0.2%) 0/587 (0%)
    Hypoxia 3/597 (0.5%) 1/587 (0.2%)
    Lung disorder 1/597 (0.2%) 0/587 (0%)
    Lung infiltration 0/597 (0%) 1/587 (0.2%)
    Organising pneumon 1/597 (0.2%) 0/587 (0%)
    Pleural effusion 5/597 (0.8%) 0/587 (0%)
    Pneumonia aspiration 2/597 (0.3%) 1/587 (0.2%)
    Pneumothorax 2/597 (0.3%) 0/587 (0%)
    Pulmonary embolism 3/597 (0.5%) 1/587 (0.2%)
    Pulmonary oedema 1/597 (0.2%) 1/587 (0.2%)
    Respiratory acidosis 1/597 (0.2%) 0/587 (0%)
    Respiratory arrest 1/597 (0.2%) 5/587 (0.9%)
    Respiratory disorder 0/597 (0%) 1/587 (0.2%)
    Respiratory distress 3/597 (0.5%) 2/587 (0.3%)
    Respiratory failure 17/597 (2.8%) 18/587 (3.1%)
    Skin and subcutaneous tissue disorders
    Rash 1/597 (0.2%) 0/587 (0%)
    Surgical and medical procedures
    Tracheal operation 0/597 (0%) 1/587 (0.2%)
    Vascular disorders
    Aortic dissection 1/597 (0.2%) 0/587 (0%)
    Circulatory collapse 1/597 (0.2%) 0/587 (0%)
    Deep vein thrombosis 0/597 (0%) 2/587 (0.3%)
    Haemorrhage 0/597 (0%) 2/587 (0.3%)
    Hypotension 5/597 (0.8%) 6/587 (1%)
    Peripheral arterial occlusive disease 1/597 (0.2%) 0/587 (0%)
    Shock 1/597 (0.2%) 1/587 (0.2%)
    Shock haemorrhagic 0/597 (0%) 1/587 (0.2%)
    Venous thrombosis 1/597 (0.2%) 0/587 (0%)
    Other (Not Including Serious) Adverse Events
    Linezolid Vancomycin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 348/597 (58.3%) 381/587 (64.9%)
    Blood and lymphatic system disorders
    Anaemia 30/597 (5%) 40/587 (6.8%)
    Coagulopathy 1/597 (0.2%) 3/587 (0.5%)
    Eosinophilia 2/597 (0.3%) 2/587 (0.3%)
    Haemorrhagic anaemia 4/597 (0.7%) 2/587 (0.3%)
    Heparin-induced thrombocytopenia 0/597 (0%) 2/587 (0.3%)
    Hypoprothrombinaemia 0/597 (0%) 1/587 (0.2%)
    Leukocytosis 2/597 (0.3%) 5/587 (0.9%)
    Lymphopenia 0/597 (0%) 1/587 (0.2%)
    Neutropenia 2/597 (0.3%) 0/587 (0%)
    Pancytopenia 2/597 (0.3%) 1/587 (0.2%)
    Thrombocytopenia 7/597 (1.2%) 12/587 (2%)
    Thrombocytosis 2/597 (0.3%) 6/587 (1%)
    Cardiac disorders
    Acute coronary syndrome 0/597 (0%) 1/587 (0.2%)
    Angina pectoris 5/597 (0.8%) 1/587 (0.2%)
    Arrhythmia 4/597 (0.7%) 2/587 (0.3%)
    Arrhythmia supraventricular 1/597 (0.2%) 0/587 (0%)
    Atrial fibrillation 10/597 (1.7%) 13/587 (2.2%)
    Atrial flutter 1/597 (0.2%) 0/587 (0%)
    Atrial tachycardia 1/597 (0.2%) 0/587 (0%)
    Bradyarrhythmia 0/597 (0%) 1/587 (0.2%)
    Bradycardia 9/597 (1.5%) 7/587 (1.2%)
    Cardiac failure 0/597 (0%) 1/587 (0.2%)
    Cardiac failure congestive 3/597 (0.5%) 3/587 (0.5%)
    Cardio-respiratory arrest 0/597 (0%) 1/587 (0.2%)
    Coronary artery disease 0/597 (0%) 1/587 (0.2%)
    Cyanosis 1/597 (0.2%) 0/587 (0%)
    Extrasystoles 0/597 (0%) 1/587 (0.2%)
    Left ventricular failure 0/597 (0%) 1/587 (0.2%)
    Myocardial infarction 2/597 (0.3%) 1/587 (0.2%)
    Pericardial effusion 1/597 (0.2%) 0/587 (0%)
    Postural orthostatic tachycardia syndrome 1/597 (0.2%) 0/587 (0%)
    Sinus bradycardia 0/597 (0%) 2/587 (0.3%)
    Sinus tachycardia 0/597 (0%) 1/587 (0.2%)
    Supraventricular extrasystoles 0/597 (0%) 1/587 (0.2%)
    Supraventricular tachycardia 7/597 (1.2%) 5/587 (0.9%)
    Tachycardia 11/597 (1.8%) 11/587 (1.9%)
    Torsade de pointes 1/597 (0.2%) 0/587 (0%)
    Ventricular dysfunction 1/597 (0.2%) 0/587 (0%)
    Ventricular extrasystoles 2/597 (0.3%) 1/587 (0.2%)
    Ventricular tachycardia 6/597 (1%) 5/587 (0.9%)
    Ear and labyrinth disorders
    Ear pain 1/597 (0.2%) 0/587 (0%)
    Hypoacusis 1/597 (0.2%) 0/587 (0%)
    Otorrhoea 0/597 (0%) 1/587 (0.2%)
    Endocrine disorders
    Adrenal insufficiency 3/597 (0.5%) 0/587 (0%)
    Diabetes insipidus 1/597 (0.2%) 1/587 (0.2%)
    Hyperparathyroidism 1/597 (0.2%) 0/587 (0%)
    Hyperthyroidism 0/597 (0%) 1/587 (0.2%)
    Hypothyroidism 0/597 (0%) 1/587 (0.2%)
    Eye disorders
    Conjunctivitis 2/597 (0.3%) 6/587 (1%)
    Corneal disorder 0/597 (0%) 1/587 (0.2%)
    Dry eye 0/597 (0%) 2/587 (0.3%)
    Ocular discomfort 0/597 (0%) 1/587 (0.2%)
    Pupillary reflex impaired 0/597 (0%) 1/587 (0.2%)
    Pupils unequal 0/597 (0%) 1/587 (0.2%)
    Uveitis 1/597 (0.2%) 0/587 (0%)
    Periorbital oedema 0/597 (0%) 1/587 (0.2%)
    Gastrointestinal disorders
    Abdominal discomfort 6/597 (1%) 0/587 (0%)
    Abdominal distension 3/597 (0.5%) 4/587 (0.7%)
    Abdominal pain 4/597 (0.7%) 4/587 (0.7%)
    Abdominal pain upper 2/597 (0.3%) 3/587 (0.5%)
    Anal ulcer 1/597 (0.2%) 0/587 (0%)
    Anorectal discomfort 1/597 (0.2%) 0/587 (0%)
    Ascites 2/597 (0.3%) 1/587 (0.2%)
    Colonic polyp 1/597 (0.2%) 0/587 (0%)
    Constipation 33/597 (5.5%) 37/587 (6.3%)
    Diarrhoea 59/597 (9.9%) 56/587 (9.5%)
    Dry mouth 0/597 (0%) 1/587 (0.2%)
    Duodenal ulcer haemorrhage 2/597 (0.3%) 1/587 (0.2%)
    Dyspepsia 3/597 (0.5%) 3/587 (0.5%)
    Dysphagia 7/597 (1.2%) 8/587 (1.4%)
    Enterocutaneous fistula 0/597 (0%) 1/587 (0.2%)
    Enterovesical fistula 1/597 (0.2%) 0/587 (0%)
    Flatulence 1/597 (0.2%) 1/587 (0.2%)
    Gastric disorder 1/597 (0.2%) 0/587 (0%)
    Gastric hypomotility 1/597 (0.2%) 0/587 (0%)
    Gastric ulcer 1/597 (0.2%) 0/587 (0%)
    Gastric ulcer haemorrhage 0/597 (0%) 1/587 (0.2%)
    Gastritis erosive 1/597 (0.2%) 0/587 (0%)
    Gastrointestinal disorder 1/597 (0.2%) 0/587 (0%)
    Gastrointestinal haemorrhage 2/597 (0.3%) 4/587 (0.7%)
    Gastrointestinal hypomotility 1/597 (0.2%) 0/587 (0%)
    Gastrointestinal motility disorder 0/597 (0%) 1/587 (0.2%)
    Gastrointestinal perforation 0/597 (0%) 1/587 (0.2%)
    Gastrooesophageal reflux disease 1/597 (0.2%) 2/587 (0.3%)
    Gingival bleeding 0/597 (0%) 1/587 (0.2%)
    Glossodynia 1/597 (0.2%) 0/587 (0%)
    Haemorrhoids 2/597 (0.3%) 2/587 (0.3%)
    Ileus 5/597 (0.8%) 3/587 (0.5%)
    Ileus paralytic 3/597 (0.5%) 0/587 (0%)
    Impaired gastric emptying 0/597 (0%) 1/587 (0.2%)
    Lip ulceration 1/597 (0.2%) 0/587 (0%)
    Lower gastrointestinal haemorrhage 1/597 (0.2%) 0/587 (0%)
    Mouth haemorrhage 1/597 (0.2%) 0/587 (0%)
    Mouth ulceration 0/597 (0%) 1/587 (0.2%)
    Nausea 22/597 (3.7%) 29/587 (4.9%)
    Oesophagitis 1/597 (0.2%) 0/587 (0%)
    Oral disorder 1/597 (0.2%) 0/587 (0%)
    Oral pain 1/597 (0.2%) 0/587 (0%)
    Pancreatitis 3/597 (0.5%) 1/587 (0.2%)
    Peptic ulcer 1/597 (0.2%) 0/587 (0%)
    Perianal erythema 0/597 (0%) 1/587 (0.2%)
    Peritonitis 1/597 (0.2%) 0/587 (0%)
    Regurgitation 0/597 (0%) 1/587 (0.2%)
    Stomatitis 1/597 (0.2%) 1/587 (0.2%)
    Swollen tongue 0/597 (0%) 1/587 (0.2%)
    Tongue ulceration 0/597 (0%) 1/587 (0.2%)
    Tooth loss 1/597 (0.2%) 0/587 (0%)
    Upper gastrointestinal haemorrhage 1/597 (0.2%) 1/587 (0.2%)
    Vomiting 14/597 (2.3%) 14/587 (2.4%)
    General disorders
    Asthenia 1/597 (0.2%) 4/587 (0.7%)
    Catheter site erythema 0/597 (0%) 1/587 (0.2%)
    Catheter site haematoma 0/597 (0%) 1/587 (0.2%)
    Catheter site haemorrhage 1/597 (0.2%) 1/587 (0.2%)
    Catheter site pain 0/597 (0%) 3/587 (0.5%)
    Chest pain 0/597 (0%) 1/587 (0.2%)
    Chills 0/597 (0%) 3/587 (0.5%)
    Device malfunction 0/597 (0%) 1/587 (0.2%)
    Device occlusion 3/597 (0.5%) 5/587 (0.9%)
    Face oedema 0/597 (0%) 1/587 (0.2%)
    Generalised oedema 11/597 (1.8%) 4/587 (0.7%)
    Hyperthermia 2/597 (0.3%) 0/587 (0%)
    Hypothermia 0/597 (0%) 6/587 (1%)
    Implant site effusion 1/597 (0.2%) 0/587 (0%)
    Infusion site erythema 1/597 (0.2%) 0/587 (0%)
    Infusion site extravasation 1/597 (0.2%) 2/587 (0.3%)
    Infusion site oedema 1/597 (0.2%) 0/587 (0%)
    Infusion site phlebitis 3/597 (0.5%) 5/587 (0.9%)
    Infusion site swelling 0/597 (0%) 1/587 (0.2%)
    Infusion site thrombosis 2/597 (0.3%) 0/587 (0%)
    Irritability 0/597 (0%) 1/587 (0.2%)
    Localised oedema 0/597 (0%) 2/587 (0.3%)
    Medical device complication 1/597 (0.2%) 0/587 (0%)
    Medical device pain 1/597 (0.2%) 1/587 (0.2%)
    Multi-organ disorder 1/597 (0.2%) 0/587 (0%)
    Non-cardiac chest pain 1/597 (0.2%) 0/587 (0%)
    Oedema 3/597 (0.5%) 2/587 (0.3%)
    Oedema peripheral 12/597 (2%) 13/587 (2.2%)
    Pain 10/597 (1.7%) 5/587 (0.9%)
    Puncture site haemorrhage 0/597 (0%) 1/587 (0.2%)
    Pyrexia 22/597 (3.7%) 24/587 (4.1%)
    Systemic inflammatory response syndrome 1/597 (0.2%) 0/587 (0%)
    Thrombosis in device 1/597 (0.2%) 1/587 (0.2%)
    Vessel puncture site haematoma 0/597 (0%) 1/587 (0.2%)
    Vessel puncture site pain 1/597 (0.2%) 0/587 (0%)
    Xerosis 1/597 (0.2%) 0/587 (0%)
    Drug withdrawal syndrome 2/597 (0.3%) 0/587 (0%)
    Hepatobiliary disorders
    Biliary fistula 0/597 (0%) 1/587 (0.2%)
    Cholangitis 1/597 (0.2%) 0/587 (0%)
    Cholecystitis 2/597 (0.3%) 1/587 (0.2%)
    Cholestasis 2/597 (0.3%) 1/587 (0.2%)
    Cytolytic hepatitis 0/597 (0%) 1/587 (0.2%)
    Hepatic cirrhosis 1/597 (0.2%) 0/587 (0%)
    Hepatic failure 0/597 (0%) 1/587 (0.2%)
    Hepatitis toxic 0/597 (0%) 1/587 (0.2%)
    Hepatobiliary disease 0/597 (0%) 1/587 (0.2%)
    Hyperbilirubinaemia 1/597 (0.2%) 2/587 (0.3%)
    Jaundice 1/597 (0.2%) 0/587 (0%)
    Immune system disorders
    Drug hypersensitivity 0/597 (0%) 1/587 (0.2%)
    Infections and infestations
    Abdominal abscess 0/597 (0%) 1/587 (0.2%)
    Abdominal infection 1/597 (0.2%) 1/587 (0.2%)
    Abscess limb 1/597 (0.2%) 0/587 (0%)
    Acinetobacter infection 1/597 (0.2%) 1/587 (0.2%)
    Bacteraemia 4/597 (0.7%) 4/587 (0.7%)
    Bacterial disease carrier 0/597 (0%) 1/587 (0.2%)
    Bacterial infection 1/597 (0.2%) 0/587 (0%)
    Bacteriuria 0/597 (0%) 1/587 (0.2%)
    Bronchitis 1/597 (0.2%) 1/587 (0.2%)
    Bronchitis bacterial 0/597 (0%) 1/587 (0.2%)
    Candida sepsis 1/597 (0.2%) 1/587 (0.2%)
    Candidiasis 4/597 (0.7%) 5/587 (0.9%)
    Candiduria 0/597 (0%) 1/587 (0.2%)
    Catheter site infection 0/597 (0%) 3/587 (0.5%)
    Cellulitis 4/597 (0.7%) 2/587 (0.3%)
    Citrobacter infection 2/597 (0.3%) 0/587 (0%)
    Clostridial infection 0/597 (0%) 1/587 (0.2%)
    Clostridium difficile colitis 7/597 (1.2%) 6/587 (1%)
    Conjunctivitis bacterial 0/597 (0%) 1/587 (0.2%)
    Cystitis 1/597 (0.2%) 0/587 (0%)
    Device related infection 3/597 (0.5%) 2/587 (0.3%)
    Device related sepsis 0/597 (0%) 2/587 (0.3%)
    Enterobacter bacteraemia 1/597 (0.2%) 0/587 (0%)
    Enterobacter pneumonia 0/597 (0%) 1/587 (0.2%)
    Enterococcal bacteraemia 0/597 (0%) 1/587 (0.2%)
    Enterococcal infection 0/597 (0%) 1/587 (0.2%)
    Escherichia urinary tract infection 2/597 (0.3%) 0/587 (0%)
    Fungal cystitis 0/597 (0%) 1/587 (0.2%)
    Fungal infection 6/597 (1%) 5/587 (0.9%)
    Fungal sepsis 1/597 (0.2%) 0/587 (0%)
    Fungal skin infection 6/597 (1%) 8/587 (1.4%)
    Gastrointestinal infection 1/597 (0.2%) 0/587 (0%)
    Genital infection fungal 0/597 (0%) 1/587 (0.2%)
    Herpes simplex 0/597 (0%) 1/587 (0.2%)
    Herpes zoster 0/597 (0%) 1/587 (0.2%)
    Infectious disease carrier 2/597 (0.3%) 0/587 (0%)
    Influenza 0/597 (0%) 1/587 (0.2%)
    Infusion site cellulitis 1/597 (0.2%) 0/587 (0%)
    Infusion site infection 1/597 (0.2%) 0/587 (0%)
    Kidney infection 1/597 (0.2%) 0/587 (0%)
    Klebsiella bacteraemia 0/597 (0%) 1/587 (0.2%)
    Klebsiella infection 1/597 (0.2%) 2/587 (0.3%)
    Lung abscess 1/597 (0.2%) 1/587 (0.2%)
    Lung infection 5/597 (0.8%) 0/587 (0%)
    Lung infection pseudomonal 6/597 (1%) 4/587 (0.7%)
    Mastitis fungal 0/597 (0%) 1/587 (0.2%)
    Meningitis 0/597 (0%) 1/587 (0.2%)
    Nasopharyngitis 1/597 (0.2%) 0/587 (0%)
    Oesophageal candidiasis 1/597 (0.2%) 0/587 (0%)
    Oral candidiasis 6/597 (1%) 5/587 (0.9%)
    Oral fungal infection 1/597 (0.2%) 1/587 (0.2%)
    Oral herpes 1/597 (0.2%) 3/587 (0.5%)
    Osteomyelitis 1/597 (0.2%) 0/587 (0%)
    Pancreatic abscess 1/597 (0.2%) 0/587 (0%)
    Pelvic abscess 0/597 (0%) 1/587 (0.2%)
    Pleural infection 1/597 (0.2%) 0/587 (0%)
    Pneumonia 3/597 (0.5%) 11/587 (1.9%)
    Pneumonia bacterial 4/597 (0.7%) 5/587 (0.9%)
    Pneumonia escherichia 1/597 (0.2%) 0/587 (0%)
    Pneumonia fungal 1/597 (0.2%) 0/587 (0%)
    Pneumonia klebsiella 2/597 (0.3%) 3/587 (0.5%)
    Pneumonia staphylococcal 1/597 (0.2%) 1/587 (0.2%)
    Pneumonia streptococcal 1/597 (0.2%) 0/587 (0%)
    Postoperative abscess 0/597 (0%) 3/587 (0.5%)
    Postoperative wound infection 3/597 (0.5%) 1/587 (0.2%)
    Pseudomembranous colitis 1/597 (0.2%) 1/587 (0.2%)
    Pseudomonas infection 0/597 (0%) 3/587 (0.5%)
    Rash pustular 0/597 (0%) 1/587 (0.2%)
    Respiratory moniliasis 0/597 (0%) 1/587 (0.2%)
    Respiratory tract infection 1/597 (0.2%) 1/587 (0.2%)
    Respiratory tract infection bacterial 1/597 (0.2%) 0/587 (0%)
    Sepsis 3/597 (0.5%) 2/587 (0.3%)
    Septic shock 1/597 (0.2%) 3/587 (0.5%)
    Sinusitis 1/597 (0.2%) 1/587 (0.2%)
    Skin candida 1/597 (0.2%) 4/587 (0.7%)
    Skin infection 1/597 (0.2%) 0/587 (0%)
    Staphylococcal bacteraemia 1/597 (0.2%) 0/587 (0%)
    Staphylococcal infection 1/597 (0.2%) 1/587 (0.2%)
    Stenotrophomonas infection 1/597 (0.2%) 0/587 (0%)
    Systemic candida 1/597 (0.2%) 0/587 (0%)
    Tinea pedis 1/597 (0.2%) 1/587 (0.2%)
    Tracheitis 1/597 (0.2%) 0/587 (0%)
    Tracheobronchitis 2/597 (0.3%) 2/587 (0.3%)
    Tracheostomy infection 1/597 (0.2%) 1/587 (0.2%)
    Upper respiratory tract infection 0/597 (0%) 1/587 (0.2%)
    Urinary tract infection 29/597 (4.9%) 19/587 (3.2%)
    Urinary tract infection fungal 3/597 (0.5%) 5/587 (0.9%)
    Urinary tract infection pseudomonal 3/597 (0.5%) 2/587 (0.3%)
    Vulvovaginal candidiasis 2/597 (0.3%) 1/587 (0.2%)
    Vulvovaginal mycotic infection 1/597 (0.2%) 1/587 (0.2%)
    Wound infection 0/597 (0%) 2/587 (0.3%)
    Wound infection bacterial 1/597 (0.2%) 0/587 (0%)
    Wound infection fungal 1/597 (0.2%) 0/587 (0%)
    Injury, poisoning and procedural complications
    Anaemia postoperative 0/597 (0%) 1/587 (0.2%)
    Anal injury 1/597 (0.2%) 0/587 (0%)
    Contusion 4/597 (0.7%) 2/587 (0.3%)
    Endotracheal intubation complication 1/597 (0.2%) 2/587 (0.3%)
    Eschar 2/597 (0.3%) 0/587 (0%)
    Excoriation 3/597 (0.5%) 5/587 (0.9%)
    Fall 1/597 (0.2%) 1/587 (0.2%)
    Feeding tube complication 2/597 (0.3%) 1/587 (0.2%)
    Foreign body 1/597 (0.2%) 0/587 (0%)
    Haematuria traumatic 1/597 (0.2%) 2/587 (0.3%)
    Hepatic haematoma 0/597 (0%) 1/587 (0.2%)
    Intentional overdose 1/597 (0.2%) 0/587 (0%)
    Joint dislocation 0/597 (0%) 1/587 (0.2%)
    Joint injury 0/597 (0%) 1/587 (0.2%)
    Mechanical ventilation complication 0/597 (0%) 1/587 (0.2%)
    Mouth injury 0/597 (0%) 1/587 (0.2%)
    Pneumothorax traumatic 1/597 (0.2%) 2/587 (0.3%)
    Post concussion syndrome 0/597 (0%) 1/587 (0.2%)
    Post procedural complication 0/597 (0%) 1/587 (0.2%)
    Post procedural discharge 0/597 (0%) 1/587 (0.2%)
    Post procedural fistula 2/597 (0.3%) 1/587 (0.2%)
    Post procedural haematoma 1/597 (0.2%) 0/587 (0%)
    Post procedural haematuria 0/597 (0%) 2/587 (0.3%)
    Post procedural haemorrhage 4/597 (0.7%) 6/587 (1%)
    Post procedural oedema 2/597 (0.3%) 2/587 (0.3%)
    Post-thoracotomy pain syndrome 1/597 (0.2%) 0/587 (0%)
    Postoperative wound complication 1/597 (0.2%) 0/587 (0%)
    Procedural pain 6/597 (1%) 5/587 (0.9%)
    Pulmonary radiation injury 1/597 (0.2%) 0/587 (0%)
    Rib fracture 1/597 (0.2%) 0/587 (0%)
    Skin injury 0/597 (0%) 1/587 (0.2%)
    Skin laceration 5/597 (0.8%) 4/587 (0.7%)
    Subdural haemorrhage 0/597 (0%) 1/587 (0.2%)
    Tendon rupture 1/597 (0.2%) 0/587 (0%)
    Therapeutic agent toxicity 1/597 (0.2%) 0/587 (0%)
    Tracheal obstruction 0/597 (0%) 1/587 (0.2%)
    Tracheostomy malfunction 1/597 (0.2%) 0/587 (0%)
    Transfusion reaction 1/597 (0.2%) 0/587 (0%)
    Wound dehiscence 1/597 (0.2%) 1/587 (0.2%)
    Investigations
    Acid base balance abnormal 1/597 (0.2%) 0/587 (0%)
    Alanine aminotransferase increased 4/597 (0.7%) 3/587 (0.5%)
    Antibiotic resistant Staphylococcus test positive 1/597 (0.2%) 1/587 (0.2%)
    Aspartate aminotransferase increased 5/597 (0.8%) 3/587 (0.5%)
    Bacterial test positive 2/597 (0.3%) 4/587 (0.7%)
    Blood albumin decreased 0/597 (0%) 1/587 (0.2%)
    Blood alkaline phosphatase increased 2/597 (0.3%) 1/587 (0.2%)
    Blood amylase increased 1/597 (0.2%) 4/587 (0.7%)
    Blood bicarbonate decreased 0/597 (0%) 1/587 (0.2%)
    Blood bilirubin increased 3/597 (0.5%) 1/587 (0.2%)
    Blood calcium decreased 0/597 (0%) 1/587 (0.2%)
    Blood chloride decreased 1/597 (0.2%) 0/587 (0%)
    Blood creatinine increased 2/597 (0.3%) 4/587 (0.7%)
    Blood culture positive 1/597 (0.2%) 0/587 (0%)
    Blood glucose decreased 0/597 (0%) 1/587 (0.2%)
    Blood glucose increased 1/597 (0.2%) 0/587 (0%)
    Blood lactate dehydrogenase increased 4/597 (0.7%) 4/587 (0.7%)
    Blood magnesium decreased 0/597 (0%) 2/587 (0.3%)
    Blood phosphorus decreased 1/597 (0.2%) 2/587 (0.3%)
    Blood potassium decreased 1/597 (0.2%) 0/587 (0%)
    Blood pressure decreased 1/597 (0.2%) 1/587 (0.2%)
    Blood pressure increased 3/597 (0.5%) 3/587 (0.5%)
    Blood sodium decreased 0/597 (0%) 1/587 (0.2%)
    Blood triglycerides increased 0/597 (0%) 1/587 (0.2%)
    Blood urea increased 0/597 (0%) 1/587 (0.2%)
    Blood urine present 0/597 (0%) 1/587 (0.2%)
    Body temperature increased 0/597 (0%) 1/587 (0.2%)
    Carbon dioxide increased 0/597 (0%) 1/587 (0.2%)
    Cardiac enzymes increased 0/597 (0%) 1/587 (0.2%)
    Chest X-ray abnormal 0/597 (0%) 1/587 (0.2%)
    Clostridium test 1/597 (0.2%) 0/587 (0%)
    Coagulation time prolonged 0/597 (0%) 1/587 (0.2%)
    Fungal test positive 4/597 (0.7%) 2/587 (0.3%)
    Gastric occult blood positive 1/597 (0.2%) 0/587 (0%)
    Haematocrit decreased 1/597 (0.2%) 1/587 (0.2%)
    Haemoglobin decreased 2/597 (0.3%) 3/587 (0.5%)
    Heart rate increased 0/597 (0%) 1/587 (0.2%)
    Hepatic enzyme increased 3/597 (0.5%) 5/587 (0.9%)
    Lipase increased 0/597 (0%) 1/587 (0.2%)
    Liver function test abnormal 4/597 (0.7%) 1/587 (0.2%)
    Neutrophil count increased 1/597 (0.2%) 0/587 (0%)
    Occult blood positive 2/597 (0.3%) 1/587 (0.2%)
    Oxygen saturation decreased 1/597 (0.2%) 2/587 (0.3%)
    Pedal pulse decreased 0/597 (0%) 1/587 (0.2%)
    Platelet count decreased 2/597 (0.3%) 0/587 (0%)
    Platelet count increased 4/597 (0.7%) 1/587 (0.2%)
    Prothrombin level decreased 1/597 (0.2%) 0/587 (0%)
    Prothrombin time prolonged 0/597 (0%) 2/587 (0.3%)
    Pulse abnormal 0/597 (0%) 1/587 (0.2%)
    Radial pulse decreased 0/597 (0%) 1/587 (0.2%)
    Red blood cell count decreased 1/597 (0.2%) 0/587 (0%)
    Reticulocyte count increased 1/597 (0.2%) 1/587 (0.2%)
    Spirometry abnormal 1/597 (0.2%) 0/587 (0%)
    Transaminases increased 3/597 (0.5%) 5/587 (0.9%)
    Troponin increased 2/597 (0.3%) 0/587 (0%)
    Urine output decreased 0/597 (0%) 2/587 (0.3%)
    Urine sodium increased 0/597 (0%) 1/587 (0.2%)
    Weight decreased 2/597 (0.3%) 0/587 (0%)
    White blood cell count increased 1/597 (0.2%) 1/587 (0.2%)
    Influenza virus test positive 0/597 (0%) 1/587 (0.2%)
    Metabolism and nutrition disorders
    Acidosis 0/597 (0%) 1/587 (0.2%)
    Cell death 1/597 (0.2%) 0/587 (0%)
    Decreased appetite 0/597 (0%) 2/587 (0.3%)
    Dehydration 3/597 (0.5%) 3/587 (0.5%)
    Diabetes mellitus 2/597 (0.3%) 2/587 (0.3%)
    Electrolyte depletion 1/597 (0.2%) 0/587 (0%)
    Electrolyte imbalance 1/597 (0.2%) 6/587 (1%)
    Fluid overload 10/597 (1.7%) 11/587 (1.9%)
    Hypercalcaemia 1/597 (0.2%) 0/587 (0%)
    Hypercreatininaemia 1/597 (0.2%) 0/587 (0%)
    Hyperglycaemia 10/597 (1.7%) 18/587 (3.1%)
    Hyperkalaemia 8/597 (1.3%) 12/587 (2%)
    Hyperlactacidaemia 1/597 (0.2%) 0/587 (0%)
    Hypermagnesaemia 0/597 (0%) 3/587 (0.5%)
    Hypernatraemia 7/597 (1.2%) 8/587 (1.4%)
    Hyperphosphataemia 2/597 (0.3%) 1/587 (0.2%)
    Hypervolaemia 0/597 (0%) 1/587 (0.2%)
    Hypoalbuminaemia 3/597 (0.5%) 8/587 (1.4%)
    Hypocalcaemia 9/597 (1.5%) 7/587 (1.2%)
    Hypochloraemia 1/597 (0.2%) 1/587 (0.2%)
    Hypoglycaemia 21/597 (3.5%) 13/587 (2.2%)
    Hypokalaemia 44/597 (7.4%) 43/587 (7.3%)
    Hypomagnesaemia 16/597 (2.7%) 15/587 (2.6%)
    Hyponatraemia 12/597 (2%) 13/587 (2.2%)
    Hypophosphataemia 11/597 (1.8%) 11/587 (1.9%)
    Hypovolaemia 3/597 (0.5%) 1/587 (0.2%)
    Iron overload 1/597 (0.2%) 0/587 (0%)
    Malnutrition 4/597 (0.7%) 3/587 (0.5%)
    Metabolic acidosis 4/597 (0.7%) 4/587 (0.7%)
    Metabolic alkalosis 6/597 (1%) 8/587 (1.4%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/597 (0.2%) 1/587 (0.2%)
    Back pain 1/597 (0.2%) 4/587 (0.7%)
    Bone disorder 0/597 (0%) 1/587 (0.2%)
    Flank pain 0/597 (0%) 1/587 (0.2%)
    Muscle rigidity 1/597 (0.2%) 2/587 (0.3%)
    Muscle twitching 0/597 (0%) 1/587 (0.2%)
    Muscular weakness 0/597 (0%) 1/587 (0.2%)
    Musculoskeletal chest pain 1/597 (0.2%) 1/587 (0.2%)
    Musculoskeletal disorder 0/597 (0%) 1/587 (0.2%)
    Musculoskeletal stiffness 1/597 (0.2%) 0/587 (0%)
    Neck pain 0/597 (0%) 1/587 (0.2%)
    Pain in extremity 5/597 (0.8%) 1/587 (0.2%)
    Rhabdomyolysis 0/597 (0%) 1/587 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant 1/597 (0.2%) 0/587 (0%)
    Lymphoma 0/597 (0%) 1/587 (0.2%)
    Renal neoplasm 1/597 (0.2%) 0/587 (0%)
    Tumour pain 1/597 (0.2%) 0/587 (0%)
    Nervous system disorders
    Aphasia 0/597 (0%) 1/587 (0.2%)
    Aphonia 1/597 (0.2%) 0/587 (0%)
    Autonomic nervous system imbalance 1/597 (0.2%) 0/587 (0%)
    Brain oedema 1/597 (0.2%) 0/587 (0%)
    Cerebral ischaemia 1/597 (0.2%) 0/587 (0%)
    Coma 1/597 (0.2%) 0/587 (0%)
    Convulsion 3/597 (0.5%) 3/587 (0.5%)
    Convulsions local 1/597 (0.2%) 0/587 (0%)
    Depressed level of consciousness 1/597 (0.2%) 0/587 (0%)
    Dizziness 2/597 (0.3%) 1/587 (0.2%)
    Encephalopathy 2/597 (0.3%) 1/587 (0.2%)
    Epilepsy 1/597 (0.2%) 0/587 (0%)
    Haemorrhage intracranial 0/597 (0%) 1/587 (0.2%)
    Headache 7/597 (1.2%) 8/587 (1.4%)
    Hemiparesis 1/597 (0.2%) 0/587 (0%)
    Hydrocephalus 1/597 (0.2%) 1/587 (0.2%)
    Hypoaesthesia 0/597 (0%) 1/587 (0.2%)
    Intracranial pressure increased 0/597 (0%) 2/587 (0.3%)
    Intraventricular haemorrhage 0/597 (0%) 1/587 (0.2%)
    Ischaemic stroke 1/597 (0.2%) 0/587 (0%)
    Lethargy 1/597 (0.2%) 3/587 (0.5%)
    Mental impairment 2/597 (0.3%) 0/587 (0%)
    Metabolic encephalopathy 1/597 (0.2%) 1/587 (0.2%)
    Muscle spasticity 0/597 (0%) 1/587 (0.2%)
    Myoclonus 1/597 (0.2%) 0/587 (0%)
    Neuromuscular blockade 1/597 (0.2%) 0/587 (0%)
    Paraesthesia 0/597 (0%) 1/587 (0.2%)
    Paralysis flaccid 0/597 (0%) 1/587 (0.2%)
    Presyncope 2/597 (0.3%) 0/587 (0%)
    Psychomotor hyperactivity 0/597 (0%) 1/587 (0.2%)
    Radial nerve palsy 0/597 (0%) 1/587 (0.2%)
    Sedation 1/597 (0.2%) 1/587 (0.2%)
    Somnolence 3/597 (0.5%) 1/587 (0.2%)
    Syncope 0/597 (0%) 1/587 (0.2%)
    Tension headache 0/597 (0%) 1/587 (0.2%)
    Tremor 0/597 (0%) 3/587 (0.5%)
    Unresponsive to stimuli 1/597 (0.2%) 0/587 (0%)
    Psychiatric disorders
    Affective disorder 1/597 (0.2%) 0/587 (0%)
    Agitation 13/597 (2.2%) 22/587 (3.7%)
    Anxiety 11/597 (1.8%) 15/587 (2.6%)
    Confusional state 5/597 (0.8%) 1/587 (0.2%)
    Delirium 4/597 (0.7%) 2/587 (0.3%)
    Depression 12/597 (2%) 7/587 (1.2%)
    Disorientation 3/597 (0.5%) 0/587 (0%)
    Hallucination 2/597 (0.3%) 1/587 (0.2%)
    Insomnia 14/597 (2.3%) 18/587 (3.1%)
    Mental status changes 1/597 (0.2%) 3/587 (0.5%)
    Post-traumatic stress disorder 0/597 (0%) 1/587 (0.2%)
    Psychotic disorder 2/597 (0.3%) 2/587 (0.3%)
    Restlessness 5/597 (0.8%) 3/587 (0.5%)
    Renal and urinary disorders
    Acute prerenal failure 1/597 (0.2%) 0/587 (0%)
    Azotaemia 1/597 (0.2%) 5/587 (0.9%)
    Chromaturia 1/597 (0.2%) 2/587 (0.3%)
    Haematuria 3/597 (0.5%) 4/587 (0.7%)
    Nephrolithiasis 0/597 (0%) 1/587 (0.2%)
    Nephropathy toxic 0/597 (0%) 1/587 (0.2%)
    Oliguria 6/597 (1%) 3/587 (0.5%)
    Pollakiuria 1/597 (0.2%) 0/587 (0%)
    Proteinuria 1/597 (0.2%) 0/587 (0%)
    Pyuria 1/597 (0.2%) 0/587 (0%)
    Renal failure 2/597 (0.3%) 8/587 (1.4%)
    Renal failure acute 5/597 (0.8%) 9/587 (1.5%)
    Renal failure chronic 0/597 (0%) 1/587 (0.2%)
    Renal impairment 3/597 (0.5%) 3/587 (0.5%)
    Urethral pain 1/597 (0.2%) 0/587 (0%)
    Urinary retention 3/597 (0.5%) 1/587 (0.2%)
    Reproductive system and breast disorders
    Genital rash 2/597 (0.3%) 0/587 (0%)
    Metrorrhagia 1/597 (0.2%) 0/587 (0%)
    Oedema genital 0/597 (0%) 1/587 (0.2%)
    Penile discharge 1/597 (0.2%) 0/587 (0%)
    Penile swelling 0/597 (0%) 1/587 (0.2%)
    Prostatism 0/597 (0%) 1/587 (0.2%)
    Scrotal oedema 1/597 (0.2%) 3/587 (0.5%)
    Scrotal swelling 0/597 (0%) 1/587 (0.2%)
    Testicular torsion 1/597 (0.2%) 0/587 (0%)
    Vulvovaginal burning sensation 1/597 (0.2%) 0/587 (0%)
    Vulvovaginal pruritus 1/597 (0.2%) 0/587 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute lung injury 1/597 (0.2%) 0/587 (0%)
    Acute respiratory distress syndrome 4/597 (0.7%) 3/587 (0.5%)
    Aspiration 1/597 (0.2%) 3/587 (0.5%)
    Asthma 2/597 (0.3%) 0/587 (0%)
    Atelectasis 3/597 (0.5%) 1/587 (0.2%)
    Bronchial obstruction 0/597 (0%) 2/587 (0.3%)
    Bronchial secretion retention 1/597 (0.2%) 1/587 (0.2%)
    Bronchospasm 4/597 (0.7%) 4/587 (0.7%)
    Chronic obstructive pulmonary disease 2/597 (0.3%) 1/587 (0.2%)
    Cough 1/597 (0.2%) 1/587 (0.2%)
    Dependence on respirator 1/597 (0.2%) 2/587 (0.3%)
    Dysphonia 2/597 (0.3%) 0/587 (0%)
    Dyspnoea 1/597 (0.2%) 6/587 (1%)
    Epistaxis 0/597 (0%) 5/587 (0.9%)
    Haemoptysis 6/597 (1%) 4/587 (0.7%)
    Hiccups 3/597 (0.5%) 2/587 (0.3%)
    Hydrothorax 1/597 (0.2%) 0/587 (0%)
    Hypercapnia 0/597 (0%) 1/587 (0.2%)
    Hypoxia 4/597 (0.7%) 3/587 (0.5%)
    Increased bronchial secretion 2/597 (0.3%) 0/587 (0%)
    Laryngeal oedema 4/597 (0.7%) 1/587 (0.2%)
    Lung consolidation 1/597 (0.2%) 0/587 (0%)
    Lung disorder 0/597 (0%) 2/587 (0.3%)
    Nasal congestion 1/597 (0.2%) 1/587 (0.2%)
    Obstructive airways disorder 0/597 (0%) 1/587 (0.2%)
    Oropharyngeal pain 4/597 (0.7%) 0/587 (0%)
    Pleural effusion 6/597 (1%) 10/587 (1.7%)
    Pleuritic pain 1/597 (0.2%) 0/587 (0%)
    Pleurocutaneous fistula 0/597 (0%) 1/587 (0.2%)
    Pneumomediastinum 0/597 (0%) 1/587 (0.2%)
    Pneumonia aspiration 2/597 (0.3%) 0/587 (0%)
    Pneumothorax 0/597 (0%) 4/587 (0.7%)
    Pneumothorax spontaneous tension 0/597 (0%) 1/587 (0.2%)
    Pulmonary alveolar haemorrhage 0/597 (0%) 1/587 (0.2%)
    Pulmonary hypertension 0/597 (0%) 1/587 (0.2%)
    Pulmonary oedema 5/597 (0.8%) 4/587 (0.7%)
    Pulmonary vascular disorder 0/597 (0%) 1/587 (0.2%)
    Respiratory acidosis 1/597 (0.2%) 2/587 (0.3%)
    Respiratory alkalosis 2/597 (0.3%) 1/587 (0.2%)
    Respiratory arrest 1/597 (0.2%) 0/587 (0%)
    Respiratory distress 0/597 (0%) 3/587 (0.5%)
    Respiratory failure 6/597 (1%) 7/587 (1.2%)
    Rhinorrhoea 0/597 (0%) 1/587 (0.2%)
    Sinus congestion 0/597 (0%) 1/587 (0.2%)
    Tachypnoea 3/597 (0.5%) 1/587 (0.2%)
    Wheezing 0/597 (0%) 3/587 (0.5%)
    Skin and subcutaneous tissue disorders
    Blister 2/597 (0.3%) 2/587 (0.3%)
    Decubitus ulcer 16/597 (2.7%) 23/587 (3.9%)
    Dermatitis 3/597 (0.5%) 1/587 (0.2%)
    Dermatitis allergic 0/597 (0%) 2/587 (0.3%)
    Dermatitis bullous 1/597 (0.2%) 0/587 (0%)
    Dermatitis contact 0/597 (0%) 2/587 (0.3%)
    Dermatitis diaper 1/597 (0.2%) 0/587 (0%)
    Dermatosis 0/597 (0%) 1/587 (0.2%)
    Drug eruption 2/597 (0.3%) 2/587 (0.3%)
    Dry skin 2/597 (0.3%) 1/587 (0.2%)
    Ecchymosis 0/597 (0%) 2/587 (0.3%)
    Eczema 1/597 (0.2%) 0/587 (0%)
    Erythema 3/597 (0.5%) 4/587 (0.7%)
    Exfoliative rash 1/597 (0.2%) 0/587 (0%)
    Hyperhidrosis 1/597 (0.2%) 1/587 (0.2%)
    Intertrigo 1/597 (0.2%) 1/587 (0.2%)
    Leukocytoclastic vasculitis 0/597 (0%) 1/587 (0.2%)
    Penile ulceration 0/597 (0%) 1/587 (0.2%)
    Plantar erythema 0/597 (0%) 1/587 (0.2%)
    Pruritus 5/597 (0.8%) 3/587 (0.5%)
    Pruritus generalised 1/597 (0.2%) 1/587 (0.2%)
    Rash 22/597 (3.7%) 20/587 (3.4%)
    Rash erythematous 1/597 (0.2%) 1/587 (0.2%)
    Rash generalised 1/597 (0.2%) 0/587 (0%)
    Rash macular 0/597 (0%) 2/587 (0.3%)
    Rash maculo-papular 0/597 (0%) 1/587 (0.2%)
    Rash papulosquamous 1/597 (0.2%) 0/587 (0%)
    Red man syndrome 0/597 (0%) 1/587 (0.2%)
    Skin discolouration 1/597 (0.2%) 1/587 (0.2%)
    Skin disorder 4/597 (0.7%) 0/587 (0%)
    Skin erosion 0/597 (0%) 1/587 (0.2%)
    Skin irritation 0/597 (0%) 1/587 (0.2%)
    Skin lesion 2/597 (0.3%) 2/587 (0.3%)
    Skin maceration 0/597 (0%) 1/587 (0.2%)
    Skin ulcer 6/597 (1%) 4/587 (0.7%)
    Subcutaneous emphysema 0/597 (0%) 2/587 (0.3%)
    Urticaria 1/597 (0.2%) 0/587 (0%)
    Papule 0/597 (0%) 1/587 (0.2%)
    Vascular disorders
    Deep vein thrombosis 1/597 (0.2%) 6/587 (1%)
    Flushing 0/597 (0%) 1/587 (0.2%)
    Haemorrhage 1/597 (0.2%) 0/587 (0%)
    Hyperaemia 0/597 (0%) 1/587 (0.2%)
    Hypertension 28/597 (4.7%) 33/587 (5.6%)
    Hypertensive crisis 1/597 (0.2%) 1/587 (0.2%)
    Hypotension 21/597 (3.5%) 35/587 (6%)
    Phlebitis 0/597 (0%) 1/587 (0.2%)
    Venous thrombosis 0/597 (0%) 1/587 (0.2%)
    Venous thrombosis limb 0/597 (0%) 1/587 (0.2%)
    Embolism arterial 1/597 (0.2%) 0/587 (0%)

    Limitations/Caveats

    EOS visit window of 15-21 days after last dose as specified in protocol was expanded during blinded evaluability assessments and prior to database lock and unblinding to 7-30 days after last dose in order to better fit the actual study visit days.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00084266
    Other Study ID Numbers:
    • A5951001
    First Posted:
    Jun 11, 2004
    Last Update Posted:
    Feb 1, 2012
    Last Verified:
    Jan 1, 2012