Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria

Phase 3

Completed

• Conditions: Bacterial Infections; Gram-Positive Bacterial Infections; Bacteremia

• Registration Number: NCT00037050
• Lead Sponsor: Pfizer

Brief Summary

This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-05-14
• Study First Submitted QC: 2002-05-14
• Study First Posted: 2002-05-15
• Study Completion: 2005-07
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-11
• Last Update Posted: 2009-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

• Patients with a central indwelling catheter with signs and symptoms of infection

Exclusion Criteria

• Patients with tunneled catheter which cannot be removed.
• Patients with evidence of endovascular infection including endocarditis.
• Patients with infection of permanent intravascular devices.
• Patients who have received more than 1 day of another antibiotic before enrollment.
• Patients with HIV and low CD4 count.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
The empiric treatment of patients with gram-positive catheter-related bloodstream infections.

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid