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

Condition(s) targeted: Bacterial Infections; Gram-Positive Bacterial Infections; Bacteremia

Intervention: Antibiotic (Drug); Vancomycin (Drug); Oxacillin (Drug); Dicloxacillin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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)

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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: 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

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Link to FDA Alert

Starting date: April 2002
Ending date: July 2005
Last updated: March 20, 2007