Full Text View
Tabular View
No Study Results Posted
Related Studies
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
This study has been completed.
First Received: May 14, 2002   Last Updated: September 11, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00037050
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
  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:
No publications provided

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

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

ClinicalTrials.gov processed this record on November 27, 2009