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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Other Adverse Events

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More Information

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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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