N/A
Completed N=42
Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
Vancomycin Resistance Enterococcus Faecium
Source: ClinicalTrials.gov NCT01224626 ↗
Enrolled (actual)
42
Serious AEs
22.0%
Results posted
Jul 2012
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions. — 10; 3; 3; 1 participants
Summary
To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions. |
10; 3; 3; 1; 1; 1 | — |
| PRIMARY Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. |
16 | — |
| SECONDARY Adverse Drug Reactions Unlisted in Japanese Package Insert. |
1; 1; 1; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject to whom Zyvox (linezolid) was administered.
- Infected subject with Vancomycin resistance Enterococcus faecium.
Exclusion Criteria
- Infected subject with MRSA and other organism.
Data sourced from ClinicalTrials.gov (NCT01224626). 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.