Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)

Completed

• Conditions: Vancomycin Resistance Enterococcus Faecium
• Interventions: Drug: Zyvox (linezolid)

• Registration Number: NCT01224626
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-03-28
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-29
• Last Update Submitted: 2012-05-29
• Results First Posted: 2012-07-02
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zyvox (linezolid)	Zyvox (linezolid)	Patients who have been treated with Zyvox (linezolid).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions.	Baseline to 8 weeks	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.	Baseline to 8 weeks	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

Name	Time	Method
Adverse Drug Reactions Unlisted in Japanese Package Insert.	Baseline to 8 weeks	The adverse drug reactions that have not been included in Japanese package insert.