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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Linezolid (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)

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


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.

Locations and Contacts

Additional Information

Link to FDA Alert

Starting date: April 2002
Last updated: September 11, 2009

Page last updated: August 23, 2015

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