Post Marketing Surveillance Study on Linezolid

Pfizer99 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gram-Positive Bacterial Infections

Interventions

LinezolidDRUG

1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days 2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days 3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.

Time frame: Baseline up to End of Treatment (EOT) (Day 10 up to 28)

Secondary Outcomes

Number of Participants With Clinical Response

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.

Time frame: EOT (Day 10 up to 28)

Data from ClinicalTrials.gov

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