Post Marketing Surveillance Study on Linezolid (A5951090)
June 27, 2012 updated by: Pfizer
Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The subjects were identified after the physician decided to prescribed the drug to the subject.
Study Type
Observational
Enrollment (Actual)
99
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult, Filipino patients diagnosed with gram positive infection
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Subjects that are diagnosed with gram positive infection
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
EOT (Day 10 up to 28)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
March 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
March 26, 2012
First Posted (Estimate)
March 28, 2012
Study Record Updates
Last Update Posted (Estimate)
August 6, 2012
Last Update Submitted That Met QC Criteria
June 27, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5951090
- GRAM POSITIVE INFECTIONS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.