Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00087490

Collaborator

(none)

1,077

Enrollment

126

Locations

Duration (Months)

8.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects

Condition or Disease	Intervention/Treatment	Phase
Skin/Soft Tissue Infections Methicillin Resistant Staphylococcus Aureus (MRSA)	Drug: linezolid Drug: vancomycin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1077 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population [EOS (6 to 28 days after the last dose of study drug)]
Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.

Secondary Outcome Measures

Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population [EOT (within 72 hours of last dose of study drug)]
CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.
Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population [EOS (6 to 28 days after the last dose of study drug)]
CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs/symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population [EOT (within 72 hours of last dose of study drug)]
CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population [EOS (6 to 28 days after the last dose of study drug)]
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population [EOT (within 72 hours of last dose of study drug)]
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population [EOS (6 to 28 days after the last dose of study drug)]
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population [EOT (within 72 hours of last dose of study drug)]
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).
Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population [EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)]
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".
Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population [EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)]
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".
Duration of Hospital Stay for PP Population [Baseline up to EOS (6 to 28 days after the last dose of study drug)]
Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.
Duration of Hospital Stay for mITT Population [Baseline up to EOS (6 to 28 days after the last dose of study drug)]
Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.
Duration of Intravenous Therapy for PP Population [Baseline up to EOS (6 to 28 days after the last dose of study drug)]
Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Duration of Intravenous Therapy for mITT Population [Baseline up to EOS (6 to 28 days after the last dose of study drug)]
Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Number of Participants Using Medical Resources [Baseline up to EOS (6 to 28 days after the last dose of study drug)]
Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
Signs and symptoms consistent with infection
Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

Exclusion Criteria:

Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Montgomery	Alabama	United States	36106
2	Pfizer Investigational Site	Tucson	Arizona	United States	85723
3	Pfizer Investigational Site	Los Angeles	California	United States	90033
4	Pfizer Investigational Site	Palm Springs	California	United States	92262
5	Pfizer Investigational Site	Rancho Mirage	California	United States	92270
6	Pfizer Investigational Site	San Pedro	California	United States	90732
7	Pfizer Investigational Site	Santa Fe Springs	California	United States	90670
8	Pfizer Investigational Site	Sylmar	California	United States	91342
9	Pfizer Investigational Site	Torrance	California	United States	90502
10	Pfizer Investigational Site	Torrance	California	United States	90503
11	Pfizer Investigational Site	Torrance	California	United States	90509
12	Pfizer Investigational Site	Denver	Colorado	United States	80205
13	Pfizer Investigational Site	Denver	Colorado	United States	80218
14	Pfizer Investigational Site	Hartford	Connecticut	United States	06102
15	Pfizer Investigational Site	Hartford	Connecticut	United States	06106
16	Pfizer Investigational Site	New Haven	Connecticut	United States	06510
17	Pfizer Investigational Site	New Haven	Connecticut	United States	06515
18	Pfizer Investigational Site	Atlantis	Florida	United States	33462
19	Pfizer Investigational Site	Melbourne	Florida	United States	32901
20	Pfizer Investigational Site	Miami	Florida	United States	33136
21	Pfizer Investigational Site	Pensacola	Florida	United States	32501-6390
22	Pfizer Investigational Site	Atlanta	Georgia	United States	30309
23	Pfizer Investigational Site	Augusta	Georgia	United States	30909
24	Pfizer Investigational Site	Blue Ridge	Georgia	United States	30513
25	Pfizer Investigational Site	Honolulu	Hawaii	United States	96813
26	Pfizer Investigational Site	Honolulu	Hawaii	United States	96817
27	Pfizer Investigational Site	Chicago	Illinois	United States	60637
28	Pfizer Investigational Site	Decatur	Illinois	United States	62526
29	Pfizer Investigational Site	Hines	Illinois	United States	60141
30	Pfizer Investigational Site	Maywood	Illinois	United States	60153
31	Pfizer Investigational Site	North Chicago	Illinois	United States	60064
32	Pfizer Investigational Site	Northlake	Illinois	United States	60164
33	Pfizer Investigational Site	Springfield	Illinois	United States	62701
34	Pfizer Investigational Site	Springfield	Illinois	United States	62702
35	Pfizer Investigational Site	Iowa City	Iowa	United States	52242
36	Pfizer Investigational Site	Louisville	Kentucky	United States	40202-1798
37	Pfizer Investigational Site	Louisville	Kentucky	United States	40217
38	Pfizer Investigational Site	Louisville	Kentucky	United States	40222
39	Pfizer Investigational Site	New Orleans	Louisiana	United States	70121
40	Pfizer Investigational Site	Baltimore	Maryland	United States	21201
41	Pfizer Investigational Site	Baltimore	Maryland	United States	21230
42	Pfizer Investigational Site	Baltimore	Maryland	United States	21237
43	Pfizer Investigational Site	Boston	Massachusetts	United States	02111
44	Pfizer Investigational Site	West Roxbury	Massachusetts	United States	02132
45	Pfizer Investigational Site	East Lansing	Michigan	United States	48824
46	Pfizer Investigational Site	Lansing	Michigan	United States	48912
47	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55422-2998
48	Pfizer Investigational Site	Mpls	Minnesota	United States	55422
49	Pfizer Investigational Site	St. Paul	Minnesota	United States	55101
50	Pfizer Investigational Site	Butte	Montana	United States	59701
51	Pfizer Investigational Site	Lincoln	Nebraska	United States	46851
52	Pfizer Investigational Site	Lincoln	Nebraska	United States	68510
53	Pfizer Investigational Site	Somers Point	New Jersey	United States	08244
54	Pfizer Investigational Site	Stony Brook	New York	United States	11794
55	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27103
56	Pfizer Investigational Site	Akron	Ohio	United States	44304
57	Pfizer Investigational Site	Akron	Ohio	United States	44309
58	Pfizer Investigational Site	Akron	Ohio	United States	44310
59	Pfizer Investigational Site	Columbus	Ohio	United States	43214
60	Pfizer Investigational Site	Columbus	Ohio	United States	43215
61	Pfizer Investigational Site	Toledo	Ohio	United States	43608
62	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19107
63	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19140
64	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19141
65	Pfizer Investigational Site	West Reading	Pennsylvania	United States	19611
66	Pfizer Investigational Site	Ducktown	Tennessee	United States	37326
67	Pfizer Investigational Site	Jackson	Tennessee	United States	38301
68	Pfizer Investigational Site	Dallas	Texas	United States	75235
69	Pfizer Investigational Site	Dallas	Texas	United States	75390-9016
70	Pfizer Investigational Site	Dallas	Texas	United States	75390
71	Pfizer Investigational Site	Fort Worth	Texas	United States	76107
72	Pfizer Investigational Site	Forth Worth	Texas	United States	76104
73	Pfizer Investigational Site	Houston	Texas	United States	77030
74	Pfizer Investigational Site	St. George	Utah	United States	84770
75	Pfizer Investigational Site	St. George	Utah	United States	84790
76	Pfizer Investigational Site	Tacoma	Washington	United States	98431
77	Pfizer Investigational Site	Loma Hermosa	Buenos Aires	Argentina	1653
78	Pfizer Investigational Site	Buenos Aires		Argentina	C1039AAO
79	Pfizer Investigational Site	Buenos Aires		Argentina	C1425DQK
80	Pfizer Investigational Site	Cordoba		Argentina	5000
81	Pfizer Investigational Site	Charleroi		Belgium	6000
82	Pfizer Investigational Site	Gent		Belgium	9000
83	Pfizer Investigational Site	Montigny-le-Tilleul		Belgium	6110
84	Pfizer Investigational Site	São José do Rio Preto	SP	Brazil	15090-000
85	Pfizer Investigational Site	São Paulo	SP	Brazil	01221-020
86	Pfizer Investigational Site	Providencia	Santiago	Chile
87	Pfizer Investigational Site	Santiago		Chile
88	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia
89	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
90	Pfizer Investigational Site	Floridablanca	Santander	Colombia
91	Pfizer Investigational Site	Genova		Italy	16132
92	Pfizer Investigational Site	Napoli		Italy	80131
93	Pfizer Investigational Site	Roma		Italy	00149
94	Pfizer Investigational Site	Roma		Italy	00168
95	Pfizer Investigational Site	Udine		Italy	33100
96	Pfizer Investigational Site	Varese		Italy	21100
97	Pfizer Investigational Site	Kuala Lumpur		Malaysia	50586
98	Pfizer Investigational Site	Kuala Lumpur		Malaysia	50603
99	Pfizer Investigational Site	Mexico	DF	Mexico	14000
100	Pfizer Investigational Site	Guadalajara	Jalisco	Mexico	44280
101	Pfizer Investigational Site	Monterrey	Nuevo Leon	Mexico	64020
102	Pfizer Investigational Site	Pragal	Almada	Portugal	2800-525
103	Pfizer Investigational Site	Amadora		Portugal	2720
104	Pfizer Investigational Site	Coimbra		Portugal	3090
105	Pfizer Investigational Site	Lisboa		Portugal	1449-005
106	Pfizer Investigational Site	Lisboa		Portugal
107	Pfizer Investigational Site	Moscow		Russian Federation	119048
108	Pfizer Investigational Site	Moscow		Russian Federation
109	Pfizer Investigational Site	Smolensk		Russian Federation
110	Pfizer Investigational Site	Singapore		Singapore	529889
111	Pfizer Investigational Site	Kuilsriver	Western Province	South Africa	7580
112	Pfizer Investigational Site	Johannesburg		South Africa	2113
113	Pfizer Investigational Site	Parow		South Africa	7499
114	Pfizer Investigational Site	Pretoria		South Africa	0001
115	Pfizer Investigational Site	Pretoria		South Africa	0184
116	Pfizer Investigational Site	Cordoba		Spain	14004
117	Pfizer Investigational Site	Gerona		Spain	17007
118	Pfizer Investigational Site	Sevilla		Spain	41013
119	Pfizer Investigational Site	Winchester	Hampshire	United Kingdom	SO22 5DG
120	Pfizer Investigational Site	Edinburgh		United Kingdom	EH4 2XU
121	Pfizer Investigational Site	Leeds		United Kingdom	LS1 3EX
122	Pfizer Investigational Site	Ciudad Bolívar	Estado Bolívar	Venezuela	8001
123	Pfizer Investigational Site	Distrito Capital	Estado Miranda	Venezuela	1040
124	Pfizer Investigational Site	Distrito Capital	Estado Miranda	Venezuela	1070
125	Pfizer Investigational Site	Maracaibo	Estado Zulia	Venezuela	4002
126	Pfizer Investigational Site	Valencia		Venezuela	2002

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00087490

Other Study ID Numbers:

A5951002

First Posted:

Jul 13, 2004

Last Update Posted:

Aug 8, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Infections

Communicable Diseases

Staphylococcal Infections

Soft Tissue Infections

Vancomycin

Linezolid

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Period Title: Overall Study
STARTED	544	533
Treated	537	515
COMPLETED	286	264
NOT COMPLETED	258	269

Baseline Characteristics

Arm/Group Title	Linezolid	Vancomycin	Total
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Total of all reporting groups
Overall Participants	537	515	1052
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.7 (17.6)	49.4 (17.2)	49.5 (17.4)
Sex: Female, Male (Count of Participants)
Female	232 43.2%	200 38.8%	432 41.1%
Male	305 56.8%	315 61.2%	620 58.9%

Outcome Measures

1. Primary Outcome

Title	Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population
Description	Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
Time Frame	EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit."N"(number of participants analyzed)=participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	227	209
Success	84.1 15.7%	79.9 15.5%
Failure	15.9 3%	20.1 3.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.249
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95% -3.0 to 11.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Description	CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.
Time Frame	EOT (within 72 hours of last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit."N"(number of participants analyzed)=participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	239	220
Success	91.6 17.1%	87.7 17%
Failure	8.4 1.6%	12.3 2.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.168
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95% -1.7 to 9.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population
Description	CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs/symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
Time Frame	EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen."N"(number of participants analyzed)= participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	276	266
Success	80.8 15%	73.7 14.3%
Failure	19.2 3.6%	26.3 5.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	7.1
	Confidence Interval	(2-Sided) 95% 0.1 to 14.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Description	CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.
Time Frame	EOT (within 72 hours of last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen."N"(number of participants analyzed)= participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	284	287
Success	89.4 16.6%	84.7 16.4%
Failure	10.6 2%	15.3 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.090
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	4.8
	Confidence Interval	(2-Sided) 95% -0.7 to 10.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Description	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).
Time Frame	EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit."N"(number of participants analyzed)=participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	228	209
Success	75.0 14%	68.4 13.3%
Failure	25.0 4.7%	31.6 6.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.127
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	6.6
	Confidence Interval	(2-Sided) 95% -1.9 to 15.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Description	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).
Time Frame	EOT (within 72 hours of last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit."N"(number of participants analyzed)=participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	239	221
Success	85.4 15.9%	68.8 13.4%
Failure	14.6 2.7%	31.2 6.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	16.6
	Confidence Interval	(2-Sided) 95% 9.0 to 24.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Description	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).
Time Frame	EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen."N"(number of participants analyzed)= participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	279	266
Success	73.5 13.7%	65.8 12.8%
Failure	26.5 4.9%	34.2 6.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	7.7
	Confidence Interval	(2-Sided) 95% -0.0 to 15.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Description	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).
Time Frame	EOT (within 72 hours of last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen."N"(number of participants analyzed)= participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	285	289
Success	84.2 15.7%	69.2 13.4%
Failure	15.8 2.9%	30.8 6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.

Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	15.0
	Confidence Interval	(2-Sided) 95% 8.2 to 21.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Number of Participants With Clinical Signs and Symptoms at EOT and 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 of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".
Time Frame	EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	229	210
Purulent discharge (mild) (EOT) (n=222, 206)	21 3.9%	17 3.3%
Purulent discharge (moderate) (EOT) (n=222, 206)	1 0.2%	5 1%
Purulent discharge (severe) (EOT) (n=222, 206)	0 0%	3 0.6%
Non-purulent discharge (mild) (EOT) (n=222, 206)	54 10.1%	57 11.1%
Non-purulent discharge (moderate) (EOT)(n=222,206)	3 0.6%	5 1%
Non-purulent discharge (severe) (EOT) (n=222, 206)	0 0%	0 0%
Erythema (mild) (EOT) (n=222, 206)	53 9.9%	62 12%
Erythema (moderate) (EOT) (n=222, 206)	1 0.2%	4 0.8%
Erythema (severe) (EOT) (n=222, 206)	0 0%	1 0.2%
Swelling (mild) (EOT) (n=222, 205)	39 7.3%	44 8.5%
Swelling (moderate) (EOT) (n=222, 205)	4 0.7%	6 1.2%
Swelling (severe) (EOT) (n=222, 205)	1 0.2%	1 0.2%
Induration (mild) (EOT) (n=222, 206)	57 10.6%	67 13%
Induration (moderate) (EOT) (n=222, 206)	3 0.6%	3 0.6%
Induration (severe) (EOT) (n=222, 206)	0 0%	0 0%
Tenderness (mild) (EOT) (n=222, 206)	62 11.5%	52 10.1%
Tenderness (moderate) (EOT) (n=222, 206)	4 0.7%	15 2.9%
Tenderness (severe) (EOT) (n=222, 206)	0 0%	2 0.4%
Pain (mild) (EOT) (n=222, 206)	38 7.1%	43 8.3%
Pain (moderate) (EOT) (n=222, 206)	4 0.7%	15 2.9%
Pain (severe) (EOT) (n=222, 206)	0 0%	2 0.4%
Local skin warmth (mild) (EOT) (n=222, 205)	14 2.6%	19 3.7%
Local skin warmth (moderate) (EOT) (n=222, 205)	0 0%	1 0.2%
Local skin warmth (severe) (EOT) (n=222, 205)	0 0%	0 0%
Purulent discharge (mild) (EOS) (n=228, 209)	10 1.9%	21 4.1%
Purulent discharge (moderate) (EOS) (n=228, 209)	2 0.4%	4 0.8%
Purulent discharge (severe) (EOS) (n=228, 209)	1 0.2%	0 0%
Non-purulent discharge (mild) (EOS) (n=227, 209)	35 6.5%	43 8.3%
Non-purulent discharge (moderate) (EOS)(n=227,209)	3 0.6%	2 0.4%
Non-purulent discharge (severe) (EOS) (n=227, 209)	0 0%	0 0%
Erythema (mild) (EOS) (n=228, 209)	25 4.7%	31 6%
Erythema (moderate) (EOS) (n=228, 209)	4 0.7%	6 1.2%
Erythema (severe) (EOS) (n=228, 209)	0 0%	0 0%
Swelling (mild) (EOS) (n=227, 208)	23 4.3%	25 4.9%
Swelling (moderate) (EOS) (n=227, 208)	0 0%	4 0.8%
Swelling (severe) (EOS) (n=227, 208)	1 0.2%	0 0%
Induration (mild) (EOS) (n=227, 209)	28 5.2%	37 7.2%
Induration (moderate) (EOS) (n=227, 209)	1 0.2%	1 0.2%
Induration (severe) (EOS) (n=227, 209)	0 0%	0 0%
Tenderness (mild) (EOS) (n=227, 209)	29 5.4%	32 6.2%
Tenderness (moderate) (EOS) (n=227, 209)	5 0.9%	4 0.8%
Tenderness (severe) (EOS) (n=227, 209)	0 0%	0 0%
Pain (mild) (EOS) (n=227, 209)	32 6%	27 5.2%
Pain (moderate) (EOS) (n=227, 209)	5 0.9%	4 0.8%
Pain (severe) (EOS) (n=227, 209)	0 0%	0 0%
Local skin warmth (mild) (EOS) (n=227, 208)	11 2%	15 2.9%
Local skin warmth (moderate) (EOS) (n=227, 208)	0 0%	2 0.4%
Local skin warmth (severe) (EOS) (n=227, 208)	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants With Clinical Signs and Symptoms at EOT and 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 of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".
Time Frame	EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	322	318
Purulent discharge (mild) (EOT) (n=286, 292)	27	25
Purulent discharge (moderate) (EOT) (n=286, 292)	3	9
Purulent discharge (severe) (EOT) (n=286, 292)	0	3
Non-purulent discharge (mild) (EOT) (n=286, 292)	71	93
Non-purulent discharge (moderate) (EOT)(n=286,292)	5	6
Non-purulent discharge (severe) (EOT) (n=286, 292)	0	0
Erythema (mild) (EOT) (n=286, 292)	72	88
Erythema (moderate) (EOT) (n=286, 292)	3	10
Erythema (severe) (EOT) (n=286, 292)	1	1
Swelling (mild) (EOT) (n=286, 291)	54	82
Swelling (moderate) (EOT) (n=286, 291)	7	9
Swelling (severe) (EOT) (n=286, 291)	1	1
Induration (mild) (EOT) (n=286, 292)	73	89
Induration (moderate) (EOT) (n=286, 292)	6	6
Induration (severe) (EOT) (n=286, 292)	0	0
Tenderness (mild) (EOT) (n=286, 292)	77	85
Tenderness (moderate) (EOT) (n=286, 292)	9	22
Tenderness (severe) (EOT) (n=286, 292)	1	2
Pain (mild) (EOT) (n=286, 292)	55	194
Pain (moderate) (EOT) (n=286, 292)	10	20
Pain (severe) (EOT) (n=286, 292)	0	3
Local skin warmth (mild) (EOT) (n=286, 290)	20	38
Local skin warmth (moderate) (EOT) (n=286, 290)	2	3
Local skin warmth (severe) (EOT) (n=286, 290)	0	0
Purulent discharge (mild) (EOS) (n=286, 270)	13	28
Purulent discharge (moderate) (EOS) (n=286, 270)	4	7
Purulent discharge (severe) (EOS) (n=286, 270)	1	1
Non-purulent discharge (mild) (EOS) (n=285, 270)	46	56
Non-purulent discharge (moderate) (EOS)(n=285,270)	5	4
Non-purulent discharge (severe) (EOS) (n=285, 270)	0	0
Erythema (mild) (EOS) (n=286, 270)	40	45
Erythema (moderate) (EOS) (n=286, 270)	6	12
Erythema (severe) (EOS) (n=286, 270)	0	0
Swelling (mild) (EOS) (n=285, 269)	33	36
Swelling (moderate) (EOS) (n=285, 269)	2	11
Swelling (severe) (EOS) (n=285, 269)	1	1
Induration (mild) (EOS) (n=285, 270)	37	44
Induration (moderate) (EOS) (n=285, 270)	2	6
Induration (severe) (EOS) (n=285, 270)	0	1
Tenderness (mild) (EOS) (n=284, 270)	49	46
Tenderness (moderate) (EOS) (n=284, 270)	6	7
Tenderness (severe) (EOS) (n=284, 270)	0	2
Pain (mild) (EOS) (n=285, 270)	49	40
Pain (moderate) (EOS) (n=285, 270)	7	7
Pain (severe) (EOS) (n=285, 270)	0	3
Local skin warmth (mild) (EOS) (n=285, 269)	20	27
Local skin warmth (moderate) (EOS) (n=285, 269)	0	4
Local skin warmth (severe) (EOS) (n=285, 269)	0	1

11. Secondary Outcome

Title	Duration of Hospital Stay for PP Population
Description	Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.
Time Frame	Baseline up to EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	229	210
Mean (Standard Error) [Days]	7.6 (0.44)	8.9 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.022
	Comments	Alpha = 0.05 was the level of significance if the null hypothesis was rejected.
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Duration of Hospital Stay for mITT Population
Description	Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.
Time Frame	Baseline up to EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	322	318
Mean (Standard Error) [Days]	7.7 (0.39)	8.9 (0.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments	Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.016
	Comments	Alpha = 0.05 was the level of significance if the null hypothesis was rejected.
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	Duration of Intravenous Therapy for PP Population
Description	Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Time Frame	Baseline up to EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit."N"(number of participants analyzed) = participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	136	210
Mean (Standard Error) [Days]	5.6 (0.35)	10.4 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

Title	Duration of Intravenous Therapy for mITT Population
Description	Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Time Frame	Baseline up to EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. "N"(number of participants analyzed)=participants evaluable for the measure.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	188	318
Mean (Standard Error) [Days]	5.3 (0.28)	9.8 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Linezolid, Vancomycin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	t-test, 2 sided
	Comments

15. Secondary Outcome

Title	Number of Participants Using Medical Resources
Description	Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.
Time Frame	Baseline up to EOS (6 to 28 days after the last dose of study drug)

Outcome Measure Data

Analysis Population Description
Data was not analyzed for the primary reporting.

Arm/Group Title	Linezolid	Vancomycin
Arm/Group Description	Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.	Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
Measure Participants	0	0

Adverse Events

	Linezolid		Vancomycin
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 infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.		Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
All Cause Mortality
	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	31/537 (5.8%)		32/515 (6.2%)
Blood and lymphatic system disorders
Anaemia	1/537 (0.2%)		0/515 (0%)
Thrombocytopenia	0/537 (0%)		1/515 (0.2%)
Cardiac disorders
Acute myocardial infarction	2/537 (0.4%)		0/515 (0%)
Angina pectoris	0/537 (0%)		1/515 (0.2%)
Cardiac arrest	1/537 (0.2%)		1/515 (0.2%)
Cardiac failure	2/537 (0.4%)		0/515 (0%)
Cardio-respiratory arrest	1/537 (0.2%)		0/515 (0%)
Myocardial infarction	1/537 (0.2%)		0/515 (0%)
Gastrointestinal disorders
Diabetic gastroparesis	1/537 (0.2%)		0/515 (0%)
Diarrhoea	1/537 (0.2%)		0/515 (0%)
Haematochezia	0/537 (0%)		1/515 (0.2%)
Intestinal ischaemia	0/537 (0%)		1/515 (0.2%)
Nausea	2/537 (0.4%)		0/515 (0%)
Pancreatitis chronic	0/537 (0%)		1/515 (0.2%)
Vomiting	1/537 (0.2%)		0/515 (0%)
General disorders
Brain death	1/537 (0.2%)		0/515 (0%)
Fatigue	1/537 (0.2%)		0/515 (0%)
Necrosis	1/537 (0.2%)		0/515 (0%)
Pyrexia	1/537 (0.2%)		0/515 (0%)
Hepatobiliary disorders
Bile duct obstruction	1/537 (0.2%)		0/515 (0%)
Infections and infestations
Abscess limb	0/537 (0%)		3/515 (0.6%)
Abscess neck	1/537 (0.2%)		0/515 (0%)
Bacterial infection	0/537 (0%)		1/515 (0.2%)
Burn infection	0/537 (0%)		1/515 (0.2%)
Cellulitis	0/537 (0%)		1/515 (0.2%)
Cellulitis gangrenous	0/537 (0%)		1/515 (0.2%)
Clostridium difficile colitis	1/537 (0.2%)		0/515 (0%)
Cystitis	0/537 (0%)		1/515 (0.2%)
Diabetic foot infection	1/537 (0.2%)		0/515 (0%)
Erysipelas	1/537 (0.2%)		0/515 (0%)
Extradural abscess	1/537 (0.2%)		0/515 (0%)
Intestinal gangrene	0/537 (0%)		1/515 (0.2%)
Mediastinitis	0/537 (0%)		1/515 (0.2%)
Osteomyelitis	1/537 (0.2%)		1/515 (0.2%)
Pneumonia	1/537 (0.2%)		2/515 (0.4%)
Postoperative wound infection	1/537 (0.2%)		2/515 (0.4%)
Sepsis	2/537 (0.4%)		1/515 (0.2%)
Septic shock	1/537 (0.2%)		0/515 (0%)
Skin infection	1/537 (0.2%)		0/515 (0%)
Subcutaneous abscess	1/537 (0.2%)		0/515 (0%)
Injury, poisoning and procedural complications
Post procedural complication	1/537 (0.2%)		0/515 (0%)
Postoperative wound complication	1/537 (0.2%)		0/515 (0%)
Wound complication	1/537 (0.2%)		0/515 (0%)
Investigations
Blood creatine increased	0/537 (0%)		1/515 (0.2%)
Blood culture positive	1/537 (0.2%)		1/515 (0.2%)
Body temperature increased	1/537 (0.2%)		0/515 (0%)
Haematocrit decreased	0/537 (0%)		1/515 (0.2%)
White blood cell count increased	0/537 (0%)		1/515 (0.2%)
Metabolism and nutrition disorders
Hyperglycaemia	0/537 (0%)		1/515 (0.2%)
Musculoskeletal and connective tissue disorders
Back pain	1/537 (0.2%)		1/515 (0.2%)
Bone disorder	1/537 (0.2%)		0/515 (0%)
Osteitis	1/537 (0.2%)		0/515 (0%)
Pain in extremity	0/537 (0%)		1/515 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin	0/537 (0%)		1/515 (0.2%)
Nervous system disorders
Brain injury	1/537 (0.2%)		0/515 (0%)
Headache	1/537 (0.2%)		0/515 (0%)
Psychiatric disorders
Major depression	1/537 (0.2%)		0/515 (0%)
Mental disorder	1/537 (0.2%)		0/515 (0%)
Renal and urinary disorders
Renal failure	1/537 (0.2%)		0/515 (0%)
Renal failure acute	0/537 (0%)		1/515 (0.2%)
Renal failure chronic	0/537 (0%)		1/515 (0.2%)
Renal impairment	0/537 (0%)		1/515 (0.2%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/537 (0%)		1/515 (0.2%)
Dyspnoea	3/537 (0.6%)		1/515 (0.2%)
Respiratory arrest	1/537 (0.2%)		0/515 (0%)
Skin and subcutaneous tissue disorders
Diabetic ulcer	0/537 (0%)		1/515 (0.2%)
Pruritus	0/537 (0%)		1/515 (0.2%)
Rash erythematous	0/537 (0%)		1/515 (0.2%)
Rash generalised	0/537 (0%)		1/515 (0.2%)
Red man syndrome	0/537 (0%)		2/515 (0.4%)
Urticaria	0/537 (0%)		1/515 (0.2%)
Surgical and medical procedures
Thrombectomy	0/537 (0%)		1/515 (0.2%)
Toe amputation	0/537 (0%)		1/515 (0.2%)
Vascular disorders
Aortic thrombosis	0/537 (0%)		1/515 (0.2%)
Arterial rupture	1/537 (0.2%)		0/515 (0%)
Peripheral arterial occlusive disease	0/537 (0%)		1/515 (0.2%)
Other (Not Including Serious) Adverse Events
	Linezolid		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	250/537 (46.6%)		250/515 (48.5%)
Blood and lymphatic system disorders
Anaemia	10/537 (1.9%)		10/515 (1.9%)
Eosinophilia	0/537 (0%)		3/515 (0.6%)
Haemorrhagic anaemia	1/537 (0.2%)		0/515 (0%)
Hypothrombinaemia	0/537 (0%)		1/515 (0.2%)
Lymphadenopathy	0/537 (0%)		1/515 (0.2%)
Neutropenia	0/537 (0%)		1/515 (0.2%)
Pancytopenia	1/537 (0.2%)		0/515 (0%)
Thrombocytopenia	2/537 (0.4%)		5/515 (1%)
Thrombocytosis	2/537 (0.4%)		0/515 (0%)
Cardiac disorders
Angina pectoris	3/537 (0.6%)		2/515 (0.4%)
Bradycardia	0/537 (0%)		1/515 (0.2%)
Cardiac failure congestive	1/537 (0.2%)		1/515 (0.2%)
Cardiomegaly	0/537 (0%)		1/515 (0.2%)
Left ventricular dysfunction	0/537 (0%)		1/515 (0.2%)
Mitral valve incompetence	1/537 (0.2%)		0/515 (0%)
Myocardial infarction	1/537 (0.2%)		0/515 (0%)
Palpitations	1/537 (0.2%)		0/515 (0%)
Sinus tachycardia	1/537 (0.2%)		0/515 (0%)
Tachyarrhythmia	0/537 (0%)		1/515 (0.2%)
Tachycardia	1/537 (0.2%)		2/515 (0.4%)
Tricuspid valve incompetence	1/537 (0.2%)		0/515 (0%)
Congenital, familial and genetic disorders
Factor XII deficiency	1/537 (0.2%)		0/515 (0%)
Ear and labyrinth disorders
Motion sickness	0/537 (0%)		1/515 (0.2%)
Tinnitus	1/537 (0.2%)		0/515 (0%)
Vertigo	1/537 (0.2%)		0/515 (0%)
Eye disorders
Conjunctivitis	1/537 (0.2%)		1/515 (0.2%)
Glaucoma	1/537 (0.2%)		0/515 (0%)
Ocular hyperaemia	0/537 (0%)		1/515 (0.2%)
Vision blurred	0/537 (0%)		2/515 (0.4%)
Gastrointestinal disorders
Abdominal discomfort	1/537 (0.2%)		1/515 (0.2%)
Abdominal distension	0/537 (0%)		2/515 (0.4%)
Abdominal pain	2/537 (0.4%)		4/515 (0.8%)
Abdominal pain upper	1/537 (0.2%)		1/515 (0.2%)
Anorectal discomfort	1/537 (0.2%)		0/515 (0%)
Ascites	1/537 (0.2%)		0/515 (0%)
Constipation	15/537 (2.8%)		17/515 (3.3%)
Diarrhoea	39/537 (7.3%)		14/515 (2.7%)
Dry mouth	6/537 (1.1%)		0/515 (0%)
Dyspepsia	7/537 (1.3%)		7/515 (1.4%)
Dysphagia	1/537 (0.2%)		0/515 (0%)
Erosive oesophagitis	0/537 (0%)		1/515 (0.2%)
Faecal incontinence	0/537 (0%)		1/515 (0.2%)
Faecalith	0/537 (0%)		1/515 (0.2%)
Flatulence	1/537 (0.2%)		1/515 (0.2%)
Food poisoning	1/537 (0.2%)		0/515 (0%)
Gastric haemorrhage	0/537 (0%)		1/515 (0.2%)
Gastric ulcer haemorrhage	0/537 (0%)		1/515 (0.2%)
Gastritis	3/537 (0.6%)		0/515 (0%)
Gastrooesophageal reflux disease	3/537 (0.6%)		0/515 (0%)
Glossodynia	1/537 (0.2%)		0/515 (0%)
Haematemesis	1/537 (0.2%)		0/515 (0%)
Haematochezia	0/537 (0%)		1/515 (0.2%)
Haemorrhoidal haemorrhage	0/537 (0%)		1/515 (0.2%)
Haemorrhoids	1/537 (0.2%)		0/515 (0%)
Hyperchlorhydria	1/537 (0.2%)		0/515 (0%)
Ileal fistula	0/537 (0%)		1/515 (0.2%)
Intestinal prolapse	1/537 (0.2%)		0/515 (0%)
Lip dry	1/537 (0.2%)		0/515 (0%)
Lip swelling	1/537 (0.2%)		1/515 (0.2%)
Nausea	55/537 (10.2%)		29/515 (5.6%)
Rectal haemorrhage	0/537 (0%)		1/515 (0.2%)
Tongue discolouration	1/537 (0.2%)		0/515 (0%)
Tongue ulceration	0/537 (0%)		1/515 (0.2%)
Vomiting	23/537 (4.3%)		11/515 (2.1%)
General disorders
Application site pruritus	0/537 (0%)		1/515 (0.2%)
Asthenia	3/537 (0.6%)		0/515 (0%)
Catheter site haematoma	0/537 (0%)		1/515 (0.2%)
Catheter site haemorrhage	0/537 (0%)		1/515 (0.2%)
Catheter site oedema	0/537 (0%)		1/515 (0.2%)
Catheter site pain	0/537 (0%)		4/515 (0.8%)
Chest discomfort	1/537 (0.2%)		0/515 (0%)
Chest pain	2/537 (0.4%)		3/515 (0.6%)
Chills	1/537 (0.2%)		1/515 (0.2%)
Cyst	0/537 (0%)		1/515 (0.2%)
Discomfort	1/537 (0.2%)		0/515 (0%)
Disease progression	0/537 (0%)		2/515 (0.4%)
Fatigue	7/537 (1.3%)		1/515 (0.2%)
Generalised oedema	1/537 (0.2%)		1/515 (0.2%)
Hyperthermia	0/537 (0%)		1/515 (0.2%)
Inflammation	0/537 (0%)		1/515 (0.2%)
Influenza like illness	1/537 (0.2%)		0/515 (0%)
Infusion site erythema	1/537 (0.2%)		3/515 (0.6%)
Infusion site extravasation	1/537 (0.2%)		14/515 (2.7%)
Infusion site oedema	1/537 (0.2%)		0/515 (0%)
Infusion site pain	1/537 (0.2%)		5/515 (1%)
Infusion site phlebitis	3/537 (0.6%)		4/515 (0.8%)
Infusion site pruritus	0/537 (0%)		1/515 (0.2%)
Infusion site rash	0/537 (0%)		1/515 (0.2%)
Infusion site reaction	0/537 (0%)		1/515 (0.2%)
Infusion site swelling	1/537 (0.2%)		1/515 (0.2%)
Infusion site thrombosis	0/537 (0%)		1/515 (0.2%)
Infusion site warmth	0/537 (0%)		1/515 (0.2%)
Injection site haematoma	1/537 (0.2%)		0/515 (0%)
Injection site pruritus	1/537 (0.2%)		0/515 (0%)
Malaise	1/537 (0.2%)		0/515 (0%)
Nodule	1/537 (0.2%)		0/515 (0%)
Oedema peripheral	6/537 (1.1%)		2/515 (0.4%)
Pain	2/537 (0.4%)		2/515 (0.4%)
Pyrexia	6/537 (1.1%)		11/515 (2.1%)
Sensation of foreign body	1/537 (0.2%)		0/515 (0%)
Ulcer	2/537 (0.4%)		0/515 (0%)
Hepatobiliary disorders
Cholecystitis	1/537 (0.2%)		0/515 (0%)
Hepatic function abnormal	0/537 (0%)		1/515 (0.2%)
Hepatitis	1/537 (0.2%)		0/515 (0%)
Hyperbilirubinaemia	0/537 (0%)		1/515 (0.2%)
Immune system disorders
Drug hypersensitivity	1/537 (0.2%)		1/515 (0.2%)
Hypersensitivity	0/537 (0%)		1/515 (0.2%)
Infections and infestations
Abdominal abscess	0/537 (0%)		1/515 (0.2%)
Abscess	1/537 (0.2%)		1/515 (0.2%)
Abscess limb	1/537 (0.2%)		2/515 (0.4%)
Abscess neck	1/537 (0.2%)		0/515 (0%)
Acarodermatitis	0/537 (0%)		1/515 (0.2%)
Asymptomatic bacteriuria	1/537 (0.2%)		0/515 (0%)
Bacteraemia	1/537 (0.2%)		0/515 (0%)
Bacterial rhinitis	0/537 (0%)		1/515 (0.2%)
Bronchitis	2/537 (0.4%)		0/515 (0%)
Candidiasis	5/537 (0.9%)		1/515 (0.2%)
Clostridium difficile colitis	0/537 (0%)		1/515 (0.2%)
Device related infection	2/537 (0.4%)		1/515 (0.2%)
Ear infection	0/537 (0%)		1/515 (0.2%)
Enterobacter infection	1/537 (0.2%)		1/515 (0.2%)
Enterococcal infection	1/537 (0.2%)		1/515 (0.2%)
Escherichia infection	1/537 (0.2%)		0/515 (0%)
Escherichia sepsis	1/537 (0.2%)		0/515 (0%)
Fungal infection	4/537 (0.7%)		2/515 (0.4%)
Fungal skin infection	4/537 (0.7%)		2/515 (0.4%)
Furuncle	1/537 (0.2%)		0/515 (0%)
Gangrene	0/537 (0%)		1/515 (0.2%)
Gastroenteritis	0/537 (0%)		2/515 (0.4%)
Genital candidiasis	2/537 (0.4%)		0/515 (0%)
Haematoma infection	1/537 (0.2%)		0/515 (0%)
Hepatitis C	0/537 (0%)		1/515 (0.2%)
Herpes simplex	0/537 (0%)		1/515 (0.2%)
Herpes zoster	0/537 (0%)		1/515 (0.2%)
Infected skin ulcer	1/537 (0.2%)		0/515 (0%)
Infection	1/537 (0.2%)		1/515 (0.2%)
Infusion site abscess	0/537 (0%)		1/515 (0.2%)
Infusion site cellulitis	1/537 (0.2%)		0/515 (0%)
Injection site abscess	0/537 (0%)		1/515 (0.2%)
Lower respiratory tract infection	1/537 (0.2%)		0/515 (0%)
Morganella infection	0/537 (0%)		1/515 (0.2%)
Nasopharyngitis	2/537 (0.4%)		0/515 (0%)
Oral candidiasis	2/537 (0.4%)		2/515 (0.4%)
Oral fungal infection	2/537 (0.4%)		0/515 (0%)
Osteomyelitis	1/537 (0.2%)		3/515 (0.6%)
Pelvic abscess	1/537 (0.2%)		0/515 (0%)
Pneumonia	2/537 (0.4%)		1/515 (0.2%)
Postoperative wound infection	1/537 (0.2%)		1/515 (0.2%)
Prostate infection	1/537 (0.2%)		0/515 (0%)
Pseudomonas infection	0/537 (0%)		2/515 (0.4%)
Pyelonephritis	1/537 (0.2%)		0/515 (0%)
Sepsis	1/537 (0.2%)		0/515 (0%)
Skin candida	2/537 (0.4%)		1/515 (0.2%)
Skin infection	2/537 (0.4%)		1/515 (0.2%)
Staphylococcal abscess	0/537 (0%)		1/515 (0.2%)
Subcutaneous abscess	0/537 (0%)		1/515 (0.2%)
Tinea cruris	2/537 (0.4%)		0/515 (0%)
Tonsillitis bacterial	1/537 (0.2%)		0/515 (0%)
Tooth abscess	0/537 (0%)		1/515 (0.2%)
Trichomoniasis	1/537 (0.2%)		0/515 (0%)
Upper respiratory tract infection	1/537 (0.2%)		1/515 (0.2%)
Urinary tract infection	13/537 (2.4%)		7/515 (1.4%)
Urinary tract infection bacterial	1/537 (0.2%)		0/515 (0%)
Urinary tract infection fungal	1/537 (0.2%)		1/515 (0.2%)
Viral infection	0/537 (0%)		1/515 (0.2%)
Viral upper respiratory tract infection	1/537 (0.2%)		1/515 (0.2%)
Vulvovaginal candidiasis	1/537 (0.2%)		1/515 (0.2%)
Vulvovaginal mycotic infection	7/537 (1.3%)		2/515 (0.4%)
Vulvovaginitis trichomonal	1/537 (0.2%)		0/515 (0%)
Wound infection	0/537 (0%)		1/515 (0.2%)
Wound infection fungal	1/537 (0.2%)		0/515 (0%)
Wound infection staphylococcal	1/537 (0.2%)		0/515 (0%)
Injury, poisoning and procedural complications
Anaemia postoperative	1/537 (0.2%)		2/515 (0.4%)
Chest injury	0/537 (0%)		1/515 (0.2%)
Contusion	1/537 (0.2%)		2/515 (0.4%)
Fall	0/537 (0%)		2/515 (0.4%)
Foot fracture	1/537 (0.2%)		0/515 (0%)
Foreign body in eye	1/537 (0.2%)		0/515 (0%)
Gastrointestinal stoma complication	0/537 (0%)		1/515 (0.2%)
Incision site pain	0/537 (0%)		1/515 (0.2%)
Infusion related reaction	0/537 (0%)		1/515 (0.2%)
Post procedural complication	1/537 (0.2%)		0/515 (0%)
Post procedural haemorrhage	1/537 (0.2%)		1/515 (0.2%)
Postoperative wound complication	0/537 (0%)		1/515 (0.2%)
Procedural nausea	2/537 (0.4%)		1/515 (0.2%)
Procedural pain	2/537 (0.4%)		2/515 (0.4%)
Seroma	1/537 (0.2%)		0/515 (0%)
Skeletal injury	0/537 (0%)		1/515 (0.2%)
Transfusion reaction	1/537 (0.2%)		0/515 (0%)
Wound dehiscence	1/537 (0.2%)		0/515 (0%)
Wound haemorrhage	1/537 (0.2%)		1/515 (0.2%)
Wound necrosis	2/537 (0.4%)		0/515 (0%)
Investigations
Alanine aminotransferase increased	5/537 (0.9%)		4/515 (0.8%)
Aspartate aminotransferase increased	2/537 (0.4%)		4/515 (0.8%)
Blood albumin decreased	0/537 (0%)		1/515 (0.2%)
Blood alkaline phosphatase increased	1/537 (0.2%)		0/515 (0%)
Blood amylase increased	2/537 (0.4%)		2/515 (0.4%)
Blood calcium decreased	1/537 (0.2%)		0/515 (0%)
Blood chloride decreased	0/537 (0%)		1/515 (0.2%)
Blood creatinine increased	0/537 (0%)		4/515 (0.8%)
Blood culture positive	1/537 (0.2%)		0/515 (0%)
Blood glucose increased	4/537 (0.7%)		1/515 (0.2%)
Blood lactate dehydrogenase increased	1/537 (0.2%)		1/515 (0.2%)
Blood magnesium decreased	1/537 (0.2%)		1/515 (0.2%)
Blood phosphorus decreased	0/537 (0%)		2/515 (0.4%)
Blood potassium decreased	1/537 (0.2%)		1/515 (0.2%)
Blood pressure decreased	1/537 (0.2%)		0/515 (0%)
Blood pressure increased	1/537 (0.2%)		1/515 (0.2%)
Blood pressure systolic increased	0/537 (0%)		1/515 (0.2%)
Body temperature increased	2/537 (0.4%)		0/515 (0%)
C-reactive protein increased	1/537 (0.2%)		2/515 (0.4%)
Culture wound positive	0/537 (0%)		1/515 (0.2%)
Drug level above therapeutic	0/537 (0%)		1/515 (0.2%)
Haematocrit decreased	1/537 (0.2%)		0/515 (0%)
Haemoglobin decreased	1/537 (0.2%)		1/515 (0.2%)
Hepatic enzyme increased	1/537 (0.2%)		2/515 (0.4%)
International normalised ratio increased	0/537 (0%)		1/515 (0.2%)
Liver function test abnormal	2/537 (0.4%)		1/515 (0.2%)
Neutrophil count decreased	1/537 (0.2%)		0/515 (0%)
Oxygen saturation decreased	1/537 (0.2%)		0/515 (0%)
Platelet count decreased	2/537 (0.4%)		0/515 (0%)
Platelet count increased	3/537 (0.6%)		0/515 (0%)
Polymerase chain reaction	1/537 (0.2%)		0/515 (0%)
Red blood cell count decreased	1/537 (0.2%)		0/515 (0%)
Urine output decreased	1/537 (0.2%)		0/515 (0%)
Weight increased	0/537 (0%)		1/515 (0.2%)
White blood cell count decreased	1/537 (0.2%)		0/515 (0%)
White blood cell count increased	0/537 (0%)		1/515 (0.2%)
Metabolism and nutrition disorders
Decreased appetite	3/537 (0.6%)		3/515 (0.6%)
Diabetes mellitus	0/537 (0%)		1/515 (0.2%)
Diabetes mellitus inadequate control	1/537 (0.2%)		1/515 (0.2%)
Hyperglycaemia	1/537 (0.2%)		2/515 (0.4%)
Hyperkalaemia	3/537 (0.6%)		2/515 (0.4%)
Hypoalbuminaemia	2/537 (0.4%)		1/515 (0.2%)
Hypocalcaemia	1/537 (0.2%)		0/515 (0%)
Hypoglycaemia	2/537 (0.4%)		7/515 (1.4%)
Hypokalaemia	9/537 (1.7%)		4/515 (0.8%)
Hypomagnesaemia	1/537 (0.2%)		0/515 (0%)
Hyponatraemia	3/537 (0.6%)		1/515 (0.2%)
Hypoproteinaemia	1/537 (0.2%)		0/515 (0%)
Malnutrition	1/537 (0.2%)		2/515 (0.4%)
Metabolic acidosis	1/537 (0.2%)		0/515 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/537 (0%)		2/515 (0.4%)
Back pain	3/537 (0.6%)		5/515 (1%)
Coccydynia	1/537 (0.2%)		0/515 (0%)
Fibromyalgia	1/537 (0.2%)		0/515 (0%)
Flank pain	1/537 (0.2%)		0/515 (0%)
Joint swelling	1/537 (0.2%)		0/515 (0%)
Muscle spasms	2/537 (0.4%)		3/515 (0.6%)
Muscular weakness	1/537 (0.2%)		0/515 (0%)
Musculoskeletal chest pain	2/537 (0.4%)		0/515 (0%)
Musculoskeletal pain	1/537 (0.2%)		1/515 (0.2%)
Myalgia	1/537 (0.2%)		0/515 (0%)
Osteoarthritis	1/537 (0.2%)		0/515 (0%)
Osteoporosis	0/537 (0%)		1/515 (0.2%)
Pain in extremity	1/537 (0.2%)		3/515 (0.6%)
Pain in jaw	1/537 (0.2%)		0/515 (0%)
Tenosynovitis	0/537 (0%)		1/515 (0.2%)
Nervous system disorders
Aphasia	0/537 (0%)		1/515 (0.2%)
Convulsion	2/537 (0.4%)		1/515 (0.2%)
Dizziness	10/537 (1.9%)		10/515 (1.9%)
Dysgeusia	3/537 (0.6%)		1/515 (0.2%)
Essential tremor	0/537 (0%)		1/515 (0.2%)
Headache	15/537 (2.8%)		19/515 (3.7%)
Hemiparesis	1/537 (0.2%)		0/515 (0%)
Hypoaesthesia	1/537 (0.2%)		0/515 (0%)
Lethargy	1/537 (0.2%)		2/515 (0.4%)
Migraine	1/537 (0.2%)		2/515 (0.4%)
Neurological decompensation	0/537 (0%)		1/515 (0.2%)
Neuropathy peripheral	0/537 (0%)		1/515 (0.2%)
Paraesthesia	2/537 (0.4%)		2/515 (0.4%)
Post polio syndrome	0/537 (0%)		1/515 (0.2%)
Presyncope	0/537 (0%)		1/515 (0.2%)
Psychomotor hyperactivity	1/537 (0.2%)		0/515 (0%)
Sedation	1/537 (0.2%)		0/515 (0%)
Somnolence	1/537 (0.2%)		5/515 (1%)
Tremor	1/537 (0.2%)		0/515 (0%)
VIIth nerve paralysis	0/537 (0%)		1/515 (0.2%)
Psychiatric disorders
Agitation	0/537 (0%)		1/515 (0.2%)
Anxiety	5/537 (0.9%)		6/515 (1.2%)
Confusional state	0/537 (0%)		2/515 (0.4%)
Depression	2/537 (0.4%)		1/515 (0.2%)
Disorientation	0/537 (0%)		1/515 (0.2%)
Hallucination	1/537 (0.2%)		0/515 (0%)
Insomnia	15/537 (2.8%)		16/515 (3.1%)
Restlessness	1/537 (0.2%)		0/515 (0%)
Sleep disorder	2/537 (0.4%)		2/515 (0.4%)
Renal and urinary disorders
Bladder spasm	0/537 (0%)		1/515 (0.2%)
Dysuria	1/537 (0.2%)		0/515 (0%)
Haematuria	3/537 (0.6%)		2/515 (0.4%)
Hydronephrosis	0/537 (0%)		1/515 (0.2%)
Leukocyturia	0/537 (0%)		1/515 (0.2%)
Oliguria	1/537 (0.2%)		1/515 (0.2%)
Renal failure	0/537 (0%)		3/515 (0.6%)
Renal impairment	3/537 (0.6%)		3/515 (0.6%)
Urinary hesitation	1/537 (0.2%)		0/515 (0%)
Urinary incontinence	1/537 (0.2%)		1/515 (0.2%)
Urinary retention	0/537 (0%)		3/515 (0.6%)
Urine odour abnormal	1/537 (0.2%)		0/515 (0%)
Reproductive system and breast disorders
Genital rash	1/537 (0.2%)		0/515 (0%)
Menorrhagia	1/537 (0.2%)		0/515 (0%)
Menstruation irregular	1/537 (0.2%)		0/515 (0%)
Ovarian cyst	1/537 (0.2%)		0/515 (0%)
Pruritus genital	1/537 (0.2%)		1/515 (0.2%)
Scrotal irritation	0/537 (0%)		1/515 (0.2%)
Vaginal disorder	1/537 (0.2%)		0/515 (0%)
Vaginal haemorrhage	0/537 (0%)		1/515 (0.2%)
Vulval disorder	1/537 (0.2%)		0/515 (0%)
Vulvovaginal pruritus	1/537 (0.2%)		1/515 (0.2%)
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction	2/537 (0.4%)		0/515 (0%)
Cough	6/537 (1.1%)		3/515 (0.6%)
Dyspnoea	3/537 (0.6%)		3/515 (0.6%)
Epistaxis	2/537 (0.4%)		2/515 (0.4%)
Hyperventilation	1/537 (0.2%)		0/515 (0%)
Hypoxia	1/537 (0.2%)		0/515 (0%)
Nasal congestion	2/537 (0.4%)		1/515 (0.2%)
Oropharyngeal blistering	1/537 (0.2%)		0/515 (0%)
Oropharyngeal pain	5/537 (0.9%)		2/515 (0.4%)
Pleural effusion	2/537 (0.4%)		0/515 (0%)
Pulmonary hypertension	1/537 (0.2%)		0/515 (0%)
Pulmonary oedema	1/537 (0.2%)		0/515 (0%)
Rales	0/537 (0%)		1/515 (0.2%)
Respiratory disorder	1/537 (0.2%)		1/515 (0.2%)
Wheezing	1/537 (0.2%)		3/515 (0.6%)
Skin and subcutaneous tissue disorders
Blood blister	1/537 (0.2%)		0/515 (0%)
Cold sweat	1/537 (0.2%)		0/515 (0%)
Decubitus ulcer	1/537 (0.2%)		2/515 (0.4%)
Dermatitis	0/537 (0%)		1/515 (0.2%)
Dermatitis contact	0/537 (0%)		1/515 (0.2%)
Drug eruption	2/537 (0.4%)		1/515 (0.2%)
Dry skin	0/537 (0%)		1/515 (0.2%)
Erythema	2/537 (0.4%)		4/515 (0.8%)
Erythema nodosum	1/537 (0.2%)		0/515 (0%)
Hyperhidrosis	1/537 (0.2%)		1/515 (0.2%)
Night sweats	0/537 (0%)		1/515 (0.2%)
Pruritus	9/537 (1.7%)		21/515 (4.1%)
Pruritus allergic	3/537 (0.6%)		1/515 (0.2%)
Pruritus generalised	0/537 (0%)		2/515 (0.4%)
Rash	10/537 (1.9%)		9/515 (1.7%)
Rash erythematous	0/537 (0%)		1/515 (0.2%)
Rash maculo-papular	1/537 (0.2%)		0/515 (0%)
Rash pruritic	0/537 (0%)		1/515 (0.2%)
Red man syndrome	0/537 (0%)		5/515 (1%)
Rosacea	1/537 (0.2%)		0/515 (0%)
Skin irritation	2/537 (0.4%)		2/515 (0.4%)
Skin reaction	0/537 (0%)		1/515 (0.2%)
Stasis dermatitis	1/537 (0.2%)		0/515 (0%)
Urticaria	0/537 (0%)		1/515 (0.2%)
Surgical and medical procedures
Venipuncture	1/537 (0.2%)		0/515 (0%)
Vascular disorders
Deep vein thrombosis	1/537 (0.2%)		1/515 (0.2%)
Flushing	0/537 (0%)		1/515 (0.2%)
Haematoma	0/537 (0%)		1/515 (0.2%)
Hot flush	0/537 (0%)		1/515 (0.2%)
Hypertension	7/537 (1.3%)		5/515 (1%)
Hypertensive crisis	0/537 (0%)		2/515 (0.4%)
Hypotension	3/537 (0.6%)		2/515 (0.4%)
Lymphoedema	1/537 (0.2%)		0/515 (0%)
Peripheral vascular disorder	1/537 (0.2%)		0/515 (0%)
Phlebitis	1/537 (0.2%)		0/515 (0%)
Shock haemorrhagic	1/537 (0.2%)		0/515 (0%)

Limitations/Caveats

Comparing duration of intravenous (IV) therapy for linezolid (LZD) and vancomycin (VAN) in study, participants in LZD group had option to switch to oral therapy while those in VAN group had to remain on IV therapy until completion of study treatment.

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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:

NCT00087490

Other Study ID Numbers:

A5951002

First Posted:

Jul 13, 2004

Last Update Posted:

Aug 8, 2012

Last Verified:

Jun 1, 2012

Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Study Details

Study Description

Brief Summary

Study Design

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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