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Trial record 1 of 1 for:    NCT00037050
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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
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 14, 2002
First Posted Date  ICMJE May 15, 2002
Last Update Posted Date September 14, 2009
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
Official Title  ICMJE Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Infections
  • Gram-Positive Bacterial Infections
  • Bacteremia
Intervention  ICMJE
  • Drug: Linezolid
    Other Name: Zyvox
  • Drug: Vancomycin
  • Drug: Oxacillin
  • Drug: Dicloxacillin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2009)
739
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Austria,   Belgium,   Brazil,   Chile,   Colombia,   Czech Republic,   France,   Germany,   Greece,   Guatemala,   Hungary,   India,   Ireland,   Italy,   Mexico,   Pakistan,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Thailand,   Turkey,   United States,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00037050
Other Study ID Numbers  ICMJE M12600080
A5951060
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP