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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00037050
First received: May 14, 2002
Last updated: September 11, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Bacterial Infections
Gram-Positive Bacterial Infections
Bacteremia
 Drug: Linezolid
Drug: Vancomycin
Drug: Oxacillin
Drug: Dicloxacillin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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

Enrollment: 739
Study Start Date: April 2002
Study Completion Date: July 2005
Intervention Details:
    Drug: Linezolid
    Other Name: Zyvox
    Drug: Vancomycin Drug: Oxacillin Drug: Dicloxacillin
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037050

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

Additional Information:
Link to FDA Alert  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00037050     History of Changes
Other Study ID Numbers: M12600080, A5951060
Study First Received: May 14, 2002
Last Updated: September 11, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Gram-Positive Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Dicloxacillin
Oxacillin
 Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013