Post Marketing Surveillance Study on Linezolid

Gram-Positive Bacterial Infections Clinical Trial

— A5951090  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564758
• Other study ID #: A5951090
• Secondary ID: GRAM POSITIVE IN
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: June 27, 2012
• Start date: February 2004
• Est. completion date: March 2005

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Gram-Positive Bacterial Infections
• Infection

Intervention

Drug:
• Linezolid
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	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)	Yes
Secondary	Number of Participants With Clinical Response	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)	No

External Links

•   To obtain contact information for a study center near you, click here.