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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00108433 |
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
Condition | Intervention | Phase |
---|---|---|
Bacteremia Gram-Positive Bacterial Infections |
Drug: Cefazolin IV Drug: Linezolid IV Drug: Vancomycin (IV) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Linezolid vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections |
Enrollment: | 63 |
Study Start Date: | September 2005 |
Study Completion Date: | September 2006 |
Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Pfizer Investigational Site | |
Baltimore, Maryland, United States, 21201 | |
Pfizer Investigational Site | |
Baltimore, Maryland, United States, 21201-1524 | |
Pfizer Investigational Site | |
Baltimore, Maryland, United States, 21230 | |
Colombia, Atlantico | |
Pfizer Investigational Site | |
Barranquilla, Atlantico, Colombia | |
Colombia, Cundinamarca | |
Pfizer Investigational Site | |
BOGOTA, Cundinamarca, Colombia, 0 | |
Colombia, D.C | |
Pfizer Investigational Site | |
Bogota, D.C, Colombia | |
India, Andhra Pradesh | |
Pfizer Investigational Site | |
Hyderbad, Andhra Pradesh, India, 500 082 | |
India, Delhi | |
Pfizer Investigational Site | |
New Delhi, Delhi, India, 110 044 | |
India, Karnataka | |
Pfizer Investigational Site | |
Bangalore, Karnataka, India, 560 054 | |
Pfizer Investigational Site | |
Bangalore, Karnataka, India, 560 034 | |
India, Punjab | |
Pfizer Investigational Site | |
Chandigarh, Punjab, India, 160 012 | |
India, Tamil Nadu | |
Pfizer Investigational Site | |
Chennai, Tamil Nadu, India, 600 004 | |
Israel | |
Pfizer Investigational Site | |
Tel-Aviv, Israel, 64239 | |
Italy | |
Pfizer Investigational Site | |
Imperia, Italy, 18100 | |
Poland | |
Pfizer Investigational Site | |
Czestochowa, Poland, 42-200 | |
Slovakia | |
Pfizer Investigational Site | |
Nitra, Slovakia, 950 01 | |
Pfizer Investigational Site | |
Banska Bystrica, Slovakia, 975 17 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5951105 |
Study First Received: | April 15, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00108433 |
Health Authority: | United States: Food and Drug Administration |
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis Gram-Positive Bacterial Infections Cefazolin |
Vancomycin Bacteremia Linezolid Inflammation |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Pathologic Processes |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |