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Post Marketing Surveillance Study on Linezolid (A5951090)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564758
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : August 6, 2012
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Gram-Positive Bacterial Infections Drug: Linezolid

Detailed Description:
The subjects were identified after the physician decided to prescribed the drug to the subject.
Study Design
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Study Type : Observational
Actual Enrollment : 99 participants
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
Study Start Date : February 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564758


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

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564758    
Other Study ID Numbers: A5951090
GRAM POSITIVE INFECTIONS
First Posted: March 28, 2012    Key Record Dates
Results First Posted: August 6, 2012
Last Update Posted: August 6, 2012
Last Verified: June 2012
Keywords provided by Pfizer:
non-interventional
non-comparative
open-label study
safety
 Linezolid
gram positive infections
Filipino
Additional relevant MeSH terms:
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Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses
Linezolid
 Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action