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

NCT00037050

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, Gram-Positive Bacterial Infections, Bacteremia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with a central indwelling catheter with signs and symptoms of infection

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Bacterial Infections, Gram-Positive Bacterial Infections, BacteremiaAntibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
NCT00037050
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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