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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00037050

Collaborator

(none)

739

Enrollment

Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections Gram-Positive Bacterial Infections Bacteremia	Drug: Linezolid Drug: Vancomycin Drug: Oxacillin Drug: Dicloxacillin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

739 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections

Study Start Date :

Apr 1, 2002

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.