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

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ClinicalTrials.gov Identifier: NCT00037050
Recruitment Status : Completed
First Posted : May 15, 2002
Last Update Posted : September 14, 2009
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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)

Condition or disease Intervention/treatment Phase
Bacterial Infections Gram-Positive Bacterial Infections Bacteremia Drug: Linezolid Drug: Vancomycin Drug: Oxacillin Drug: Dicloxacillin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 739 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
Study Start Date : April 2002
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Linezolid
    Other Name: Zyvox
    Drug: Vancomycin Drug: Oxacillin Drug: Dicloxacillin

Primary Outcome Measures :
  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.

Secondary Outcome Measures :
  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

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037050

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00037050     History of Changes
Other Study ID Numbers: M12600080
First Posted: May 15, 2002    Key Record Dates
Last Update Posted: September 14, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action