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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014