Post Marketing Surveillance Study on Linezolid (A5951090)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564758
First received: March 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Gram-Positive Bacterial Infections
Drug: Linezolid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to End of Treatment (EOT) (Day 10 up to 28) ] [ Designated as safety issue: Yes ]
    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:
  • Number of Participants With Clinical Response [ Time Frame: EOT (Day 10 up to 28) ] [ Designated as safety issue: No ]
    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.


Enrollment: 99
Study Start Date: February 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects that are diagnosed with gram positive infection
Drug: Linezolid
  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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult, Filipino patients diagnosed with gram positive infection

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564758

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564758     History of Changes
Other Study ID Numbers: A5951090, GRAM POSITIVE INFECTIONS
Study First Received: March 26, 2012
Results First Received: June 27, 2012
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
non-interventional
non-comparative
open-label study
safety
Linezolid
gram positive infections
Filipino

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014