- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037050
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
September 11, 2009 updated by: Pfizer
Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
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)
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
739
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
May 14, 2002
First Submitted That Met QC Criteria
May 14, 2002
First Posted (Estimate)
May 15, 2002
Study Record Updates
Last Update Posted (Estimate)
September 14, 2009
Last Update Submitted That Met QC Criteria
September 11, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Bacterial Infections and Mycoses
- Sepsis
- Infections
- Communicable Diseases
- Bacteremia
- Bacterial Infections
- Gram-Positive Bacterial Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Vancomycin
- Linezolid
- Dicloxacillin
- Oxacillin
Other Study ID Numbers
- M12600080
- A5951060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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