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

Tracking Information

First Received Date ^ICMJE

May 14, 2002

Last Updated Date

September 11, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

1.The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
2. The empiric treatment of patients with gram-positive catheter-related bloodstream infections.

Change History

Complete list of historical versions of study NCT00037050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

1.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 or vancomycin/oxacillin/dicloxacillin.
3.Pathogen eradication.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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)

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Bacterial Infections
Gram-Positive Bacterial Infections
Bacteremia

Intervention ^ICMJE

Drug: Linezolid
Drug: Vancomycin
Drug: Oxacillin
Drug: Dicloxacillin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

739

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00037050

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

M12600080, A5951060

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP