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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037050
• Other study ID #: M12600080
• Secondary ID: A5951060
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2002
• Last updated: September 11, 2009
• Start date: April 2002
• Est. completion date: July 2005

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infection

Intervention

Drug:
• Linezolid

• Vancomycin

• Oxacillin

• Dicloxacillin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
Primary	The empiric treatment of patients with gram-positive catheter-related bloodstream infections.
Secondary	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

External Links

•   Link to FDA Alert