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

This study has been completed.

First Received: May 14, 2002 Last Updated: September 11, 2009 History of Changes

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

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: Linezolid Drug: Vancomycin Drug: Oxacillin Drug: Dicloxacillin	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Oxacillin Dicloxacillin sodium Linezolid Vancomycin Vancomycin hydrochloride Dicloxacillin

U.S. FDA Resources

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

Enrollment:	739
Study Start Date:	April 2002
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

Additional Information:

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

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	M12600080, A5951060
Study First Received:	May 14, 2002
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00037050 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Communicable Diseases
Dicloxacillin
Molecular Mechanisms of Pharmacological Action
Bacteremia
Oxacillin
Enzyme Inhibitors
Infection

Pharmacologic Actions
Inflammation
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Sepsis
Pathologic Processes
Therapeutic Uses
Vancomycin
Linezolid

ClinicalTrials.gov processed this record on November 27, 2009