Trial · NCT00084266
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT00084266, Phase 4, Completed, Pfizer; results first posted 2011-05-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA). Trials, record NCT00084266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00084266
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
- NCT number
- NCT00084266
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,225 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Methicillin Resistant Staphylococcus Aureus (MRSA)
- Interventions
- linezolid (Zyvox), vancomycin
- First posted
- 2004-06-11
- Last updated
- 2012-02-01
- Results first posted
- 2011-05-09
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | 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. |
| Secondary | Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population | 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. |
| Secondary | Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | 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. |
| Secondary | Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population | 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. |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population | 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. |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population | 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. |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population | 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. |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population | 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. |
| Secondary | Number of Participants With Clinical Signs and Symptoms at EOS for PP Population | 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. |
| Secondary | Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | EOS (7-30 days after last dose) | PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population | EOS (7-30 days after last dose) | mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | EOT (within 72 hours of last dose) | PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population | EOT (within 72 hours of last dose) | mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population | EOS (7-30 days after last dose) | PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population | EOS (7-30 days after last dose) | mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population | EOT (within 72 hours of last dose) | PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population | EOT (within 72 hours of last dose) | mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Signs and Symptoms at EOS for PP Population | EOS (7-30 days after last dose) | PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population | EOS (7-30 days after last dose) | mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit. | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | Linezolid | Cure | 95 | Participants | |
| Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | Vancomycin | Cure | 81 | Participants | |
| Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | Linezolid | Failure | 70 | Participants | |
| Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | Vancomycin | Failure | 93 | Participants | |
| Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | Linezolid | Unknown/Missing (excluded from analysis) | 7 | Participants | |
| Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population | Vancomycin | Unknown/Missing (excluded from analysis) | 2 | Participants | |
| Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population | Linezolid | Cure | 102 | Participants | |
| Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population | Vancomycin | Cure | 92 | Participants | |
| Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population | Linezolid | Failure | 84 | Participants | |
| Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population | Vancomycin | Failure | 113 | Participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Linezolid | 618 | |
| Overall Study | STARTED | Vancomycin | 607 | |
| Overall Study | Treated | Linezolid | 597 | |
| Overall Study | Treated | Vancomycin | 587 | |
| Overall Study | COMPLETED | Linezolid | 177 | |
| Overall Study | COMPLETED | Vancomycin | 184 | |
| Overall Study | NOT COMPLETED | Linezolid | 441 | |
| Overall Study | NOT COMPLETED | Vancomycin | 423 |
Source ClinicalTrials.gov
Adverse events1,522
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Linezolid | 30 | 597 | |
| other | Anaemia | Blood and lymphatic system disorders | Vancomycin | 40 | 587 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Linezolid | 1 | 597 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Vancomycin | 3 | 587 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Linezolid | 2 | 597 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Vancomycin | 2 | 587 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Linezolid | 4 | 597 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Vancomycin | 2 | 587 | |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Linezolid | 0 | 597 | |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Vancomycin | 2 | 587 |
1 to 10 of 1,522Source ClinicalTrials.gov
See all 1,522 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Linezolid | ||
| Total, all-cause mortality | Vancomycin | ||
| Total, other adverse events | Linezolid | 348 | 597 |
| Total, other adverse events | Vancomycin | 381 | 587 |
| Total, serious adverse events | Linezolid | 145 | 597 |
| Total, serious adverse events | Vancomycin | 141 | 587 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Linezolid vs Vancomycin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00084266
GET https://conductscience.org/api/trials/v1/NCT00084266/results?page=2