Post Marketing Surveillance Study on Linezolid (A5951090)
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|ClinicalTrials.gov Identifier: NCT01564758|
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : August 6, 2012
Last Update Posted : August 6, 2012
|Condition or disease||Intervention/treatment|
|Gram-Positive Bacterial Infections||Drug: Linezolid|
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|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|
Subjects that are diagnosed with gram positive infection
- 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.
- 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.
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
|Study Director:||Pfizer CT.gov Call Center||Pfizer|