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

Purpose

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	Intervention	Phase
Bacterial Infections Gram-Positive Bacterial Infections Bacteremia	Drug: Antibiotic Drug: Vancomycin Drug: Oxacillin Drug: Dicloxacillin	Phase III

MedlinePlus related topics:

Antibiotics Bacterial Infections

ChemIDplus related topics:

Vancomycin Linezolid Vancomycin hydrochloride Dicloxacillin Dicloxacillin sodium Oxacillin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

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

Estimated Enrollment:	960
Study Start Date:	April 2002
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037050

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Link to FDA Alert This link exits the ClinicalTrials.gov site

Study ID Numbers:	M12600080, A5951060
First Received:	May 14, 2002
Last Updated:	March 20, 2007
ClinicalTrials.gov Identifier:	NCT00037050
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Bacterial Infections

Sepsis

Gram-Positive Bacterial Infections

Dicloxacillin

Oxacillin

Vancomycin

Bacteremia

Linezolid

Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Communicable Diseases

Pathologic Processes

Therapeutic Uses

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00037050