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OpenTrials
Completed

NCT Number: NCT01564758

Post Marketing Surveillance Study on Linezolid

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

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Key information

Conditions

Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linezolid

Drug
  • 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

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: 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 outcomes

  1. Number of Participants With Clinical Response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: A5951090

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Mar 28, 2012
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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