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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00084266

First received: June 9, 2004

Last updated: January 30, 2012

Last verified: January 2012

History of Changes

Results First Received: March 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Methicillin Resistant Staphylococcus Aureus (MRSA)
Interventions:	Drug: linezolid (Zyvox) Drug: vancomycin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Linezolid	Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin	Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.

Participant Flow: Overall Study

	Linezolid	Vancomycin
STARTED	618	607
Treated	597	587
COMPLETED	177	184
NOT COMPLETED	441	423
Death	42	39
Adverse Event	8	5
Lack of Efficacy	2	4
Lost to Follow-up	5	3
Participant not willing to participate	3	8
Unspecified	360	344
Randomized not treated	21	20

Baseline Characteristics

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Reporting Groups

	Description
Linezolid	Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin	Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Total	Total of all reporting groups

Baseline Measures

	Linezolid	Vancomycin	Total
Number of Participants [units: participants]	597	587	1184
Age [units: Years] Mean ± Standard Deviation	60.5 ± 18.4	60.5 ± 18.4	60.5 ± 18.4
Gender [units: Participants]
Female	202	207	409
Male	395	380	775
Clinical Signs and Symptoms for modified intent-to-treat (mITT) Population ^[1] [units: Participants]
Decreased Breath Sounds	169	182	351
Hypoxia	164	151	315
Pulmonary Consolidation	173	184	357
Rales	172	177	349
Tachypnea	152	143	295
Chills/Rigors	22	11	33
Cough	122	107	229
Dyspnea	99	95	194
Pleuritic Chest Pain	14	12	26
Purulent Sputum	167	209	376
Clinical Signs and Symptoms for Per Protocol (PP) Population ^[2] [units: Participants]
Decreased Breath Sounds	138	155	293
Hypoxia	133	127	260
Pulmonary Consolidation	145	158	303
Rales	142	149	291
Tachypnea	124	123	247
Chills/Rigors	18	9	27
Cough	101	90	191
Dyspnea	80	80	160
Pleuritic Chest Pain	12	9	21
Purulent Sputum	171	174	345

[1]	Clinical signs and symptoms (mild to severe):cough;production of purulent sputum;auscultatory finding on pulmonary examination of rales,pulmonary consolidation(dullness on percussion, bronchial breath sounds,egophony);dyspnea, tachypnea,hypoxemia with partial pressure of oxygen(PaO2)<60 mmHg/worsening gas exchange/increased O2 requirement.
[2]	Clinical signs and symptoms (mild to severe):cough;production of purulent sputum;auscultatory finding on pulmonary examination of rales,pulmonary consolidation(dullness on percussion, bronchial breath sounds,egophony);dyspnea, tachypnea,hypoxemia with PaO2<60 mmHg/worsening gas exchange/increased O2 requirement.

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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Serious Adverse Events

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Time Frame	No text entered.
Additional 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.

Reporting Groups

	Description
Linezolid	Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin	Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.

Serious Adverse Events

	Linezolid	Vancomycin
Total, serious adverse events
# participants affected / at risk	145/597 (24.29%)	141/587 (24.02%)
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Disseminated intravascular coagulation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Haemorrhagic anaemia ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Neutropenia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Thrombocytopenia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Thrombotic thrombocytopenic purpura ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Cardiac disorders
Acute myocardial infarction ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Atrial fibrillation ^{* 1}
# participants affected / at risk	2/597 (0.34%)	3/587 (0.51%)
Bradyarrhythmia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Bradycardia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Cardiac arrest ^{* 1}
# participants affected / at risk	11/597 (1.84%)	13/587 (2.21%)
Cardiac failure congestive ^{* 1}
# participants affected / at risk	1/597 (0.17%)	5/587 (0.85%)
Cardiac tamponade ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Cardio-respiratory arrest ^{* 1}
# participants affected / at risk	9/597 (1.51%)	4/587 (0.68%)
Cardiogenic shock ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Cardiomyopathy ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Cardiopulmonary failure ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Coronary artery disease ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Electromechanical dissociation ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Myocardial infarction ^{* 1}
# participants affected / at risk	3/597 (0.50%)	0/587 (0.00%)
Myocardial ischaemia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Pericardial effusion ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Pericarditis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Supraventricular tachycardia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Tachycardia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Gastrointestinal disorders
Abdominal pain ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Ascites ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Diarrhoea ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Diverticular perforation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Diverticulum intestinal haemorrhagic ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Enterocutaneous fistula ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Gastric ulcer haemorrhage ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Gastrointestinal haemorrhage ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Gastrointestinal necrosis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Ileus ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Intestinal dilatation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Intestinal ischaemia ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Intestinal perforation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Large intestine perforation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Lower gastrointestinal haemorrhage ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Mesenteric vein thrombosis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Nausea ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Oesophageal achalasia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Oesophageal varices haemorrhage ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Pancreatitis ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Peritonitis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Small intestinal perforation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Upper gastrointestinal haemorrhage ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Vomiting ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
General disorders
Drug ineffective ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Multi-organ disorder ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Multi-organ failure ^{* 1}
# participants affected / at risk	7/597 (1.17%)	3/587 (0.51%)
Pyrexia ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Secretion discharge ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Hepatobiliary disorders
Cholecystitis ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Cholecystitis acute ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Hepatic cirrhosis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Ischaemic hepatitis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Liver disorder ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Immune system disorders
Hypersensitivity ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Infections and infestations
Abdominal abscess ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Abdominal infection ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Abdominal sepsis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Abscess intestinal ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Acinetobacter bacteraemia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Acinetobacter infection ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Bacterial sepsis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Candidiasis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Cellulitis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Clostridial infection ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Clostridium colitis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Clostridium difficile colitis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Device related infection ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Diverticulitis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Endocarditis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Fungal sepsis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Gangrene ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Kidney infection ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Lung infection pseudomonal ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Meningitis bacterial ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Muscle abscess ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Parotitis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Pneumonia ^{* 1}
# participants affected / at risk	14/597 (2.35%)	9/587 (1.53%)
Pneumonia bacterial ^{* 1}
# participants affected / at risk	1/597 (0.17%)	3/587 (0.51%)
Pneumonia klebsiella ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Pneumonia staphylococcal ^{* 1}
# participants affected / at risk	1/597 (0.17%)	3/587 (0.51%)
Post procedural sepsis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Postoperative abscess ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Postoperative wound infection ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Pseudomonal bacteraemia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Pseudomonas infection ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Pyothorax ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Sepsis ^{* 1}
# participants affected / at risk	9/597 (1.51%)	19/587 (3.24%)
Septic shock ^{* 1}
# participants affected / at risk	9/597 (1.51%)	16/587 (2.73%)
Staphylococcal infection ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Staphylococcal sepsis ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Systemic candida ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Toxic shock syndrome streptococcal ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Tracheobronchitis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Urinary tract infection ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Wound infection staphylococcal ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Injury, poisoning and procedural complications
Anastomotic complication ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Brain herniation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Failure to anastomose ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Fall ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Gastrointestinal stoma complication ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Pneumothorax traumatic ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Post procedural fistula ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Postoperative ileus ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Seroma ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Tracheal obstruction ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Tracheostomy malfunction ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Wound dehiscence ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Wound evisceration ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Metabolism and nutrition disorders
Dehydration ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Hyperkalaemia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Hypoglycaemia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Musculoskeletal and connective tissue disorders
Bursitis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Fistula ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Osteonecrosis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Neuroendocrine carcinoma ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Squamous cell carcinoma ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Ureteric cancer metastatic ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Nervous system disorders
Brain compression ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Brain oedema ^{* 1}
# participants affected / at risk	3/597 (0.50%)	0/587 (0.00%)
Cerebral ischaemia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Cerebrovascular accident ^{* 1}
# participants affected / at risk	2/597 (0.34%)	3/587 (0.51%)
Coma ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Convulsion ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Depressed level of consciousness ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Haemorrhage intracranial ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Haemorrhagic stroke ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Headache ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Hydrocephalus ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Hypoxic-ischaemic encephalopathy ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Ischaemic stroke ^{* 1}
# participants affected / at risk	1/597 (0.17%)	2/587 (0.34%)
Mental impairment ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Nervous system disorder ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Neurological decompensation ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Pneumocephalus ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Polyneuropathy ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Subarachnoid haemorrhage ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Subdural hygroma ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Unresponsive to stimuli ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Psychiatric disorders
Mental status changes ^{* 1}
# participants affected / at risk	0/597 (0.00%)	3/587 (0.51%)
Renal and urinary disorders
Azotaemia ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Renal failure ^{* 1}
# participants affected / at risk	2/597 (0.34%)	6/587 (1.02%)
Renal failure acute ^{* 1}
# participants affected / at risk	5/597 (0.84%)	11/587 (1.87%)
Renal failure chronic ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Renal impairment ^{* 1}
# participants affected / at risk	3/597 (0.50%)	1/587 (0.17%)
Urinary retention ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Acute respiratory distress syndrome ^{* 1}
# participants affected / at risk	3/597 (0.50%)	1/587 (0.17%)
Acute respiratory failure ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Apnoea ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Asphyxia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Aspiration ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Atelectasis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Brain hypoxia ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Bronchial secretion retention ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Bronchospasm ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Chronic obstructive pulmonary disease ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Dependence on respirator ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Epistaxis ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Haemoptysis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Hypoventilation ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Hypoxia ^{* 1}
# participants affected / at risk	3/597 (0.50%)	1/587 (0.17%)
Lung disorder ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Lung infiltration ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Organising pneumon ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Pleural effusion ^{* 1}
# participants affected / at risk	5/597 (0.84%)	0/587 (0.00%)
Pneumonia aspiration ^{* 1}
# participants affected / at risk	2/597 (0.34%)	1/587 (0.17%)
Pneumothorax ^{* 1}
# participants affected / at risk	2/597 (0.34%)	0/587 (0.00%)
Pulmonary embolism ^{* 1}
# participants affected / at risk	3/597 (0.50%)	1/587 (0.17%)
Pulmonary oedema ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Respiratory acidosis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Respiratory arrest ^{* 1}
# participants affected / at risk	1/597 (0.17%)	5/587 (0.85%)
Respiratory disorder ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Respiratory distress ^{* 1}
# participants affected / at risk	3/597 (0.50%)	2/587 (0.34%)
Respiratory failure ^{* 1}
# participants affected / at risk	17/597 (2.85%)	18/587 (3.07%)
Skin and subcutaneous tissue disorders
Rash ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Surgical and medical procedures
Tracheal operation ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Vascular disorders
Aortic dissection ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Circulatory collapse ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Deep vein thrombosis ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Haemorrhage ^{* 1}
# participants affected / at risk	0/597 (0.00%)	2/587 (0.34%)
Hypotension ^{* 1}
# participants affected / at risk	5/597 (0.84%)	6/587 (1.02%)
Peripheral arterial occlusive disease ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)
Shock ^{* 1}
# participants affected / at risk	1/597 (0.17%)	1/587 (0.17%)
Shock haemorrhagic ^{* 1}
# participants affected / at risk	0/597 (0.00%)	1/587 (0.17%)
Venous thrombosis ^{* 1}
# participants affected / at risk	1/597 (0.17%)	0/587 (0.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 13.0

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
EOS visit window of 15-21 days after last dose as specified in protocol was expanded during blinded evaluability assessments and prior to database lock and unblinding to 7-30 days after last dose in order to better fit the actual study visit days.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00084266 History of Changes
Other Study ID Numbers:	A5951001
Study First Received:	June 9, 2004
Results First Received:	March 10, 2011
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

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