Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
This study has been completed.
Information provided by (Responsible Party):
First received: October 18, 2010
Last updated: May 29, 2012
Last verified: May 2012
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)|
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Adverse Drug Reactions. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: Yes ]All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.
- Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.
Secondary Outcome Measures:
- Adverse Drug Reactions Unlisted in Japanese Package Insert. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: Yes ]The adverse drug reactions that have not been included in Japanese package insert.
|Study Start Date:||May 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Patients who have been treated with Zyvox (linezolid).
Drug: Zyvox (linezolid)
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
Other Name: linezolid, Zyvox
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