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

January 30, 2012 updated by: Pfizer

Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina, 1181
        • Pfizer Investigational Site
  • Belgium
      • Brugge, Belgium, 8000
        • Pfizer Investigational Site
      • Brussels, Belgium, 1070
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Liege 1, Belgium, B-4000
        • Pfizer Investigational Site
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40420-000
        • Pfizer Investigational Site
    • SP
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 05651-901
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile
        • Pfizer Investigational Site
    • RM
      • Santiago, RM, Chile
        • Pfizer Investigational Site
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Pfizer Investigational Site
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Pfizer Investigational Site
    • Bogota. DC
      • Bogota, Bogota. DC, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
    • Tolima
      • Ibague, Tolima, Colombia
        • Pfizer Investigational Site
  • France
      • Marseille Cedex 20, France, 13915
        • Pfizer Investigational Site
      • Paris, France, 75013
        • Pfizer Investigational Site
      • Saint Etienne Cedex 02, France, 42055
        • Pfizer Investigational Site
    • Cedex 18
      • Paris, Cedex 18, France, 75877
        • Pfizer Investigational Site
  • Germany
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
      • Leipzig, Germany, 04289
        • Pfizer Investigational Site
      • Leipzig, Germany, 04129
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 10676
        • Pfizer Investigational Site
      • Crete, Greece, 71110
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 57010
        • Pfizer Investigational Site
    • Athens
      • Kifisia, Athens, Greece, 14561
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 150-713
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 134-701
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
  • Mexico
    • DF
      • Mexico, DF, Mexico, 14000
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Pfizer Investigational Site
    • Nuevo Léon
      • Monterrey/Col. Mitras Centro, Nuevo Léon, Mexico, 64460
        • Pfizer Investigational Site
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Pfizer Investigational Site
  • Poland
      • Bytom, Poland, 41-902
        • Pfizer Investigational Site
      • Katowice, Poland, 40-752
        • Pfizer Investigational Site
      • Krakow, Poland, 31 - 066
        • Pfizer Investigational Site
      • Krakow, Poland, 31-066
        • Pfizer Investigational Site
  • Portugal
      • Almada, Portugal, 2800
        • Pfizer Investigational Site
      • Coimbra, Portugal, 3041
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1449-005
        • Pfizer Investigational Site
      • Senhora da Hora, Portugal, 4464-513
        • Pfizer Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Pfizer Investigational Site
      • San Juan, Puerto Rico, 00921-3201
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 113093
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 111539
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115446
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123448
        • Pfizer Investigational Site
    • Russia
      • Moscow, Russia, Russian Federation, 117049
        • Pfizer Investigational Site
  • South Africa
      • Auckland Park, South Africa, 2006
        • Pfizer Investigational Site
      • Bloefontein, South Africa, 9301
        • Pfizer Investigational Site
      • Soweto, South Africa, 2013
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Pfizer Investigational Site
      • Pan-Chiao, Taiwan, 220
        • Pfizer Investigational Site
      • Taichung, Taiwan, 404
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Pfizer Investigational Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35249
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36111
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Redlands, California, United States, 92373
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94110
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80205
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20017
        • Pfizer Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Jackson, Florida, United States, 32209
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32209
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32801
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33607
        • Pfizer Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30030
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • North Chicago, Illinois, United States, 60064
        • Pfizer Investigational Site
      • Oak Park, Illinois, United States, 60302-2566
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62701
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62702
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62703
        • Pfizer Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47151
        • Pfizer Investigational Site
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40536
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40206
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01199
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0331
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48210
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110-1010
        • Pfizer Investigational Site
      • St. Loius, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Pfizer Investigational Site
      • Reno, Nevada, United States, 89502
        • Pfizer Investigational Site
      • Reno, Nevada, United States, 89503
        • Pfizer Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10457
        • Pfizer Investigational Site
      • Brooklyn, New York, United States, 11215
        • Pfizer Investigational Site
      • Buffalo, New York, United States, 14215
        • Pfizer Investigational Site
      • New York, New York, United States, 10029
        • Pfizer Investigational Site
      • New York, New York, United States, 10011
        • Pfizer Investigational Site
      • New York, New York, United States, 10021-9800
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642-8410
        • Pfizer Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58112
        • Pfizer Investigational Site
      • Fargo, North Dakota, United States, 58122
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45267-0558
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43214
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43215
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43222
        • Pfizer Investigational Site
      • Sylvania, Ohio, United States, 43560
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43608
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43614
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97220
        • Pfizer Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Bethlehem, Pennsylvania, United States, 18017
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19102
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Pfizer Investigational Site
      • Sioux Falls, South Dakota, United States, 57104
        • Pfizer Investigational Site
      • Sioux Falls, South Dakota, United States, 57117-5045
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232-7110
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030-1608
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75061
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78284
        • Pfizer Investigational Site
      • San Marcos, Texas, United States, 78666
        • Pfizer Investigational Site
      • Sequin, Texas, United States, 78155
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Utah
      • Murray, Utah, United States, 84157
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Pfizer Investigational Site
      • Winchester, Virginia, United States, 22601
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
  • Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
  • Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Exclusion Criteria:

  • Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
  • Subjects with severe neutropenia (<500 cells/mm3)
  • Subjects with hypersensitivity to oxazolidinones or vancomycin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Subjects receiving linezolid for the treatment phase of the study
Drug: linezolid (Zyvox)
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Other Names:
  • Zyvox, linezolid
Active Comparator: 2
Subjects receiving vancomycin for the treatment phase of the study
Drug: vancomycin
Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
EOS (7-30 days after last dose)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population
Time Frame: EOS (7-30 days after last dose)
Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
EOS (7-30 days after last dose)
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Time Frame: EOT (within 72 hours of last dose)
Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
EOT (within 72 hours of last dose)
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Time Frame: EOT (within 72 hours of last dose)
Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Time Frame: EOS (7-30 days after last dose)
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Time Frame: EOS (7-30 days after last dose)
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Time Frame: EOT (within 72 hours of last dose)
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Time Frame: EOT (within 72 hours of last dose)
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for PP Population
Time Frame: EOS (7-30 days after last dose)
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population
Time Frame: EOS (7-30 days after last dose)
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for PP Population
Time Frame: EOT (within 72 hours of last dose)
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population
Time Frame: EOT (within 72 hours of last dose)
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
EOT (within 72 hours of last dose)
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.
For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
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.
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.
For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
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.
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.
For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A5951001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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