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

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

Sponsors

Lead Sponsor: Pfizer

Source

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)

Overall Status

Completed

Start Date

April 2002

Completion Date

July 2005

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure	Time Frame
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

Measure	Time Frame
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

Enrollment

739

Condition

Intervention

Intervention Type: Drug

Intervention Name: Linezolid

Other Name: Zyvox

Intervention Type: Drug

Intervention Name: Vancomycin

Intervention Type: Drug

Intervention Name: Oxacillin

Intervention Type: Drug

Intervention Name: Dicloxacillin

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 13 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official

Last Name	Role	Affiliation
Pfizer CT.gov Call Center	Study Director	Pfizer

Verification Date

September 2009

Responsible Party

Name Title: Director, Clinical Trial Disclosure Group

Organization: Pfizer, Inc.

Condition Browse

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov