Post Marketing Surveillance Study on Linezolid

NCT01564758 | Completed Results

• 2 other identifiers: A5951090GRAM POSITIVE INFECTIONS
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gram-Positive Bacterial Infections

Keywords

non-interventional; non-comparative; open-label study; safety; Linezolid; gram positive infections; Filipino

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Number of Participants With Clinical Response

  EOT (Day 10 up to 28)

Study Arms (1)

Group 1

Subjects that are diagnosed with gram positive infection

Drug: Linezolid

Interventions

Linezolid DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult, Filipino patients diagnosed with gram positive infection

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity
• Subjects diagnosed with pure gram-negative infection

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: February 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: August 6, 2012
• Results First Posted: August 6, 2012

Record last verified: 2012-06