Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00108433
• Collaborator: (none)
• Enrollment: 61
• Locations: 17
• Duration (Months): 12
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).

Condition or Disease	Intervention/Treatment	Phase
Bacteremia; Gram-Positive Bacterial Infections	Drug: Cefazolin IV; Drug: Linezolid IV; Drug: Vancomycin (IV)	Phase 3

Detailed Description

Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Linezolid vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit [Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)]

   Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.

Secondary Outcome Measures

1. Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment [EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)]

   Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.

2. Number of Participants With Complications During Therapy [LTFU visit (6 to 8 weeks after the last dose of study medication)]

   Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.

3. Percentage of Pathogens Eradicated [STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)]

   Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.

4. Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization [STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)]

   Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• To be eligible for this study, a patient must provide informed consent and must meet all of the following criteria. No study procedures, including any baseline tests, should be performed until the patient (or parent/legally acceptable representative, if appropriate) legally signs the informed consent form.

• Male or female, 18 years of age or older and >= 40 kg body weight

• End-stage renal disease patients on hemodialysis with: A) Signs and symptoms of a localized catheter-related infection (eg tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site); OR B) A body temperature of >= 38.0 C or < 36.0 C (oral equivalent); OR C) A Gram-positive blood culture. If the Gram-positive isolate is S. aureus, it must be cultured from at least 1 culture bottle from either the peripheral set or the catheter set of culture bottles. For all other Gram-positive pathogens (eg, coagulase-negative staphylococci), isolates need to be cultured from at least 2 culture bottles of which one must be from the peripheral set. There must be no other obvious source of the bacteremia

• Presence of at least one of the following systemic signs of infection (may be obtained up to 24 hours prior to baseline): *Hypotension, defined as systolic blood pressure <90 mmHg or its reduction by >= 40 mmHg from the patient's baseline, in the absence of other causes for hypotension; *Tachycardia defined as a pulse rate > 90 beats per minute; *Tachypnea defined as a respiratory rate > 20 breaths per minute or PACO2 <32 torr; *White blood count >10,000 cells/mm3 or < 4,000 cells/mm3, or with a differential count showing >10% band neutrophil forms.

• Patients on hemodialysis with tunneled or nontunneled catheters including antibiotic coated hemodialysis catheters. Patients may have more than one concurrent catheter.

• Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

• Patients presenting with any of the following will not be included in this study:

• Catheter-related bloodstream infections caused by Gram-negative bacteria, fungi, mixed cultures of Gram negative bacteria and Gram positive bacteria or mixed cultures of Gram positive/negative bacteria and fungi

• Patients with evidence of other infections resulting in bacteremia, such as clinical or radiographic signs of osteomyelitis, endocarditis, skin/skin structure infection, pneumonia, urinary tract infection, joint infection, intraabdominal infection, septic thrombophlebitis or other infection

• Patients in whom the infected catheter cannot be removed

• Patients with permanent intravascular devices such as artificial vascular grafts, implantable pacemakers or defibrillators; intra-aortic balloon pumps, and left ventricular assist device; intravascular transplants such as prosthetic cardiac valves; or non-intravascular devices such as peritoneal dialysis catheters; or neurosurgical devices such as ventriculo-peritoneal shunts, intra-cranial pressure monitors, or epidural catheters, prosthetic cardiac valves, prosthetic vascular grafts, or other internal prosthesis

• Females of child-bearing potential who are unable or unwilling to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant

• Identification of a pathogen resistant to linezolid or vancomycin

• Patients who are unlikely to survive through the treatment period and evaluation

• Administration of a glycopeptide antibiotic within 5 days prior to enrollment. Administration of other potentially effective systemic Gram-positive antibiotics for more than 48 hours within 72 hours prior to enrollment unless the pathogen showed drug resistance

• Previous enrollment in this protocol

• Hypersensitivity to linezolid, vancomycin, gentamicin or one of their excipients (or aztreonam if non-bacteremic Gram-negative coverage is required)

• Concurrent use of another investigational medication or use within 30 days of study entry

• Patients with pressor and fluid-resistant hemodynamic compromise or pulmonary embolism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Baltimore	Maryland	United States	21201-1524
2	Pfizer Investigational Site	Baltimore	Maryland	United States	21201
3	Pfizer Investigational Site	Baltimore	Maryland	United States	21230
4	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia
5	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	0
6	Pfizer Investigational Site	Bogota	D.C	Colombia
7	Pfizer Investigational Site	Hyderbad	Andhra Pradesh	India	500 082
8	Pfizer Investigational Site	New Delhi	Delhi	India	110 044
9	Pfizer Investigational Site	Bangalore	Karnataka	India	560 034
10	Pfizer Investigational Site	Bangalore	Karnataka	India	560 054
11	Pfizer Investigational Site	Chandigarh	Punjab	India	160 012
12	Pfizer Investigational Site	Chennai	Tamil Nadu	India	600 004
13	Pfizer Investigational Site	Tel-Aviv		Israel	64239
14	Pfizer Investigational Site	Imperia		Italy	18100
15	Pfizer Investigational Site	Czestochowa		Poland	42-200
16	Pfizer Investigational Site	Banska Bystrica		Slovakia	975 17
17	Pfizer Investigational Site	Nitra		Slovakia	950 01

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: NCT00108433
• Other Study ID Numbers: A5951105
• First Posted: Apr 18, 2005
• Last Update Posted: Aug 7, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Bacteremia; Sepsis; Gram-Positive Bacterial Infections; Vancomycin; Cefazolin; Linezolid

Study Results

Participant Flow

Arm/Group Title	Linezolid	Vancomycin/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Period Title: Overall Study
STARTED	30	31
COMPLETED	9	14
NOT COMPLETED	21	17

Baseline Characteristics

Arm/Group Title	Linezolid	Vancomycin/Cefazolin	Total
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.	Total of all reporting groups
Overall Participants	30	31	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.4 (17.7)	49.7 (15.4)	52.0 (16.6)
Sex: Female, Male (Count of Participants)
Female	13 43.3%	13 41.9%	26 42.6%
Male	17 56.7%	18 58.1%	35 57.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Description	Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.
Time Frame	Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)

Outcome Measure Data

Analysis Population Description

Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.

Arm/Group Title	Linezolid	Vancomycin/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Measure Participants	0	0

2. Secondary Outcome

Title	Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment
Description	Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.
Time Frame	EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)

Outcome Measure Data

Analysis Population Description

Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.

Arm/Group Title	Linezolid	Vancomycin/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Measure Participants	0	0

3. Secondary Outcome

Title	Number of Participants With Complications During Therapy
Description	Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.
Time Frame	LTFU visit (6 to 8 weeks after the last dose of study medication)

Outcome Measure Data

Analysis Population Description

Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.

Arm/Group Title	Linezolid	Vancomycin/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Measure Participants	0	0

4. Secondary Outcome

Title	Percentage of Pathogens Eradicated
Description	Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.
Time Frame	STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)

Outcome Measure Data

Analysis Population Description

Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.

Arm/Group Title	Linezolid	Vancomycin/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Measure Participants	0	0

5. Secondary Outcome

Title	Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization
Description	Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.
Time Frame	STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)

Outcome Measure Data

Analysis Population Description

Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.

Arm/Group Title	Linezolid	Vancomycin/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.	Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Measure Participants	0	0

Adverse Events

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/Cefazolin
Arm/Group Description	Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.		Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
All Cause Mortality
	Linezolid		Vancomycin/Cefazolin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Linezolid		Vancomycin/Cefazolin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)		3/31 (9.7%)
Cardiac disorders
Cardiopulmonary failure	1/30 (3.3%)		0/31 (0%)
Myocardial infarction	1/30 (3.3%)		0/31 (0%)
Gastrointestinal disorders
Diarrhoea	0/30 (0%)		1/31 (3.2%)
Duodenal ulcer	1/30 (3.3%)		0/31 (0%)
Vomiting	1/30 (3.3%)		0/31 (0%)
General disorders
Chills	1/30 (3.3%)		0/31 (0%)
Death	0/30 (0%)		1/31 (3.2%)
Pyrexia	1/30 (3.3%)		1/31 (3.2%)
Infections and infestations
Bronchopneumonia	1/30 (3.3%)		0/31 (0%)
Endocarditis	1/30 (3.3%)		0/31 (0%)
Metabolism and nutrition disorders
Fluid overload	1/30 (3.3%)		0/31 (0%)
Vascular disorders
Hypertension	0/30 (0%)		1/31 (3.2%)
Hypertensive crisis	1/30 (3.3%)		0/31 (0%)
Hypotension	1/30 (3.3%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Linezolid		Vancomycin/Cefazolin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/30 (40%)		9/31 (29%)
Cardiac disorders
Supraventricular tachycardia	1/30 (3.3%)		0/31 (0%)
Gastrointestinal disorders
Abdominal pain upper	1/30 (3.3%)		0/31 (0%)
Dyspepsia	1/30 (3.3%)		1/31 (3.2%)
Gastric ulcer	1/30 (3.3%)		0/31 (0%)
Gastritis	1/30 (3.3%)		0/31 (0%)
Nausea	2/30 (6.7%)		1/31 (3.2%)
Oesophagitis	1/30 (3.3%)		0/31 (0%)
Vomiting	6/30 (20%)		1/31 (3.2%)
General disorders
Asthenia	0/30 (0%)		1/31 (3.2%)
Pyrexia	2/30 (6.7%)		3/31 (9.7%)
Infections and infestations
Candidiasis	1/30 (3.3%)		0/31 (0%)
Endocarditis	0/30 (0%)		1/31 (3.2%)
Psoas abscess	0/30 (0%)		1/31 (3.2%)
Sepsis	1/30 (3.3%)		0/31 (0%)
Viral infection	0/30 (0%)		1/31 (3.2%)
Investigations
Aspartate aminotransferase increased	0/30 (0%)		1/31 (3.2%)
Metabolism and nutrition disorders
Hypoglycaemia	0/30 (0%)		1/31 (3.2%)
Musculoskeletal and connective tissue disorders
Back pain	0/30 (0%)		1/31 (3.2%)
Nervous system disorders
Grand mal convulsion	1/30 (3.3%)		0/31 (0%)
Psychiatric disorders
Agitation	1/30 (3.3%)		0/31 (0%)
Anxiety	0/30 (0%)		1/31 (3.2%)
Renal and urinary disorders
Bladder outlet obstruction	0/30 (0%)		1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis	1/30 (3.3%)		0/31 (0%)
Skin and subcutaneous tissue disorders
Erythema	1/30 (3.3%)		0/31 (0%)
Rash	0/30 (0%)		1/31 (3.2%)
Vascular disorders
Hypotension	1/30 (3.3%)		0/31 (0%)
Jugular vein thrombosis	0/30 (0%)		1/31 (3.2%)
Subclavian vein thrombosis	0/30 (0%)		1/31 (3.2%)

Limitations/Caveats

Efficacy results were not reported because the study was prematurely terminated.

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.