Trial · NCT00087490
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT00087490, Phase 4, Completed, Pfizer; results first posted 2012-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA). Trials, record NCT00087490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00087490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
- NCT number
- NCT00087490
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,077 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Skin/Soft Tissue Infections, Methicillin Resistant Staphylococcus Aureus (MRSA)
- Interventions
- linezolid, vancomycin
- First posted
- 2004-07-13
- Last updated
- 2012-08-08
- Results first posted
- 2012-08-08
- Limitations and caveats
Comparing duration of intravenous (IV) therapy for linezolid (LZD) and vancomycin (VAN) in study, participants in LZD group had option to switch to oral therapy while those in VAN group had to remain on IV therapy until completion of study treatment.
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 Per-Protocol (PP) Population | EOS (6 to 28 days after the last dose of study drug) | Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis. |
| Secondary | Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | EOT (within 72 hours of last dose of study drug) | CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis. |
| Secondary | Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population | EOS (6 to 28 days after the last dose of study drug) | CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs/symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis. |
| Secondary | Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population | EOT (within 72 hours of last dose of study drug) | CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis. |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population | EOS (6 to 28 days after the last dose of study drug) | Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT). |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population | EOT (within 72 hours of last dose of study drug) | Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture). |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population | EOS (6 to 28 days after the last dose of study drug) | Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT). |
| Secondary | Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population | EOT (within 72 hours of last dose of study drug) | Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture). |
| Secondary | Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population | EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) | Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe". |
| Secondary | Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population | EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) | Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe". |
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 Per-Protocol (PP) Population | EOS (6 to 28 days after the last dose of study drug) | PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure. | Percentage of 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 of study drug) | PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population | EOS (6 to 28 days after the last dose of study drug) | mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population | EOT (within 72 hours of last dose of study drug) | mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population | EOS (6 to 28 days after the last dose of study drug) | PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population | EOT (within 72 hours of last dose of study drug) | PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population | EOS (6 to 28 days after the last dose of study drug) | mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population | EOT (within 72 hours of last dose of study drug) | mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population | EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) | PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population | EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) | mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms. | Partcipants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group232
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 Per-Protocol (PP) Population | Linezolid | Success | 84.1 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population | Vancomycin | Success | 79.9 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population | Linezolid | Failure | 15.9 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population | Vancomycin | Failure | 20.1 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | Linezolid | Success | 91.6 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | Vancomycin | Success | 87.7 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | Linezolid | Failure | 8.4 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population | Vancomycin | Failure | 12.3 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population | Linezolid | Success | 80.8 | Percentage of participants | |
| Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population | Vancomycin | Success | 73.7 | Percentage of participants |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 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 | 544 | |
| Overall Study | STARTED | Vancomycin | 533 | |
| Overall Study | Treated | Linezolid | 537 | |
| Overall Study | Treated | Vancomycin | 515 | |
| Overall Study | COMPLETED | Linezolid | 286 | |
| Overall Study | COMPLETED | Vancomycin | 264 | |
| Overall Study | NOT COMPLETED | Linezolid | 258 | |
| Overall Study | NOT COMPLETED | Vancomycin | 269 |
Source ClinicalTrials.gov
Adverse events872
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 | 10 | 537 | |
| other | Anaemia | Blood and lymphatic system disorders | Vancomycin | 10 | 515 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Linezolid | 0 | 537 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Vancomycin | 3 | 515 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Linezolid | 1 | 537 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Vancomycin | 0 | 515 | |
| other | Hypothrombinaemia | Blood and lymphatic system disorders | Linezolid | 0 | 537 | |
| other | Hypothrombinaemia | Blood and lymphatic system disorders | Vancomycin | 1 | 515 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Linezolid | 0 | 537 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Vancomycin | 1 | 515 |
1 to 10 of 872Source ClinicalTrials.gov
See all 872 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 | 250 | 537 |
| Total, other adverse events | Vancomycin | 250 | 515 |
| Total, serious adverse events | Linezolid | 31 | 537 |
| Total, serious adverse events | Vancomycin | 32 | 515 |
Source ClinicalTrials.gov
Papers2
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/NCT00087490
GET https://conductscience.org/api/trials/v1/NCT00087490/results?page=2