Post Marketing Surveillance Study on Linezolid

Completed

• Conditions: Gram-Positive Bacterial Infections
• Interventions: Drug: Linezolid

• Registration Number: NCT01564758
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

Detailed Description

The subjects were identified after the physician decided to prescribed the drug to the subject.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Status Verified: 2012-06
• Results First Submitted: 2012-06-27
• Results First Submitted QC: 2012-06-27
• Last Update Submitted: 2012-06-27
• Results First Posted: 2012-08-06
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Linezolid	Subjects that are diagnosed with gram positive infection

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Baseline up to End of Treatment (EOT) (Day 10 up to 28)	Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response	EOT (Day 10 up to 28)	Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.