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

Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)

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 Overview

• Status: Completed
• Conditions: Vancomycin Resistance Enterococcus Faecium
• Intervention / Treatment: Drug: Zyvox (linezolid)

• Study Type: Observational
• Enrollment (Actual): 41

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients who are prescribed to Zyvox (linezolid).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Zyvox (linezolid); Patients who have been treated with Zyvox (linezolid).	Drug: Zyvox (linezolid); Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.; Other Names: linezolid, Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Drug Reactions.	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.	Baseline to 8 weeks
Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.	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.	Baseline to 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: May 29, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Japanese; VRE; Post Marketing Surveillance
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: A5951139