Post Marketing Surveillance Study on Linezolid

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

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

Official Title
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Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections

Conditions
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Gram-Positive Bacterial Infections

Intervention / Treatment
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* Drug: Linezolid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Subjects that are diagnosed with gram positive infection | Drug: Linezolid<br>* Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to End of Treatment (EOT) (Day 10 up to 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | EOT (Day 10 up to 28) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-interventional, non-comparative, open-label study, safety, Linezolid, gram positive infections, Filipino