Back to resultsAntibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
Primary Purpose
Bacterial Infections, Gram-Positive Bacterial Infections, Bacteremia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Linezolid
Vancomycin
Oxacillin
Dicloxacillin
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infections
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00037050
Brief Title
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
Official Title
Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Gram-Positive Bacterial Infections, Bacteremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
739 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Type
Drug
Intervention Name(s)
Oxacillin
Intervention Type
Drug
Intervention Name(s)
Dicloxacillin
Primary Outcome Measure Information:
Title
The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
Title
The empiric treatment of patients with gram-positive catheter-related bloodstream infections.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101503.htm
Description
Link to FDA Alert
Learn more about this trial
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
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