Phase 4
N=1,225
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Methicillin Resistant Staphylococcus Aureus (MRSA)
Bottom Line
View on ClinicalTrials.gov: NCT00084266 ↗Enrolled (actual)
1,225
Serious AEs
24.2%
Results posted
May 2011
Primary outcome: Primary: Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population — 95; 81; 70; 93 Participants — p=0.042
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- linezolid (Zyvox) (Drug); vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population |
95; 81; 70; 93; 7; 2 | 0.042 sig |
| SECONDARY Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population |
102; 92; 84; 113; 38; 19 | — |
| SECONDARY Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population |
76; 70; 74; 60; 30; 56 | — |
| SECONDARY Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population |
81; 77; 80; 68; 40; 69 | — |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population |
35; 26; 62; 56; 7; 15 | — |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population |
46; 35; 65; 61; 9; 22 | — |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population |
76; 59; 73; 55; 16; 50 | — |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population |
84; 65; 77; 62; 19; 60 | — |
| SECONDARY Number of Participants With Clinical Signs and Symptoms at EOS for PP Population |
42; 46; 30; 29; 22; 19 | — |
| SECONDARY Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population |
53; 58; 38; 38; 32; 27 | — |
| SECONDARY Number of Participants With Clinical Signs and Symptoms at EOT for PP Population |
63; 99; 56; 60; 43; 69 | — |
| SECONDARY Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population |
73; 109; 67; 73; 53; 77 | — |
| SECONDARY Survival Status Estimated by Kaplan-Meier Analysis for PP Population |
59.196; 57.191 | 0.9344 |
| SECONDARY Survival Status Estimated by Kaplan-Meier Analysis for mITT Population |
58.185; 57.072 | 0.5985 |
| SECONDARY Survival Status Estimated by Kaplan-Meier Analysis for ITT Population |
55.590; 55.369 | 0.8590 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00084266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.