N/A
Completed N=99
Post Marketing Surveillance Study on Linezolid
Gram-Positive Bacterial Infections
Source: ClinicalTrials.gov NCT01564758 ↗
Enrolled (actual)
99
Serious AEs
10.1%
Results posted
Aug 2012
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 15 participants
Summary
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
15 | — |
| SECONDARY Number of Participants With Clinical Response |
57; 31; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
- Male or female, 18 years old and above
Exclusion Criteria
- Known hypersensitivity
- Subjects diagnosed with pure gram-negative infection
Data sourced from ClinicalTrials.gov (NCT01564758). 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. Informational only — not medical advice.