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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00108433 |
Purpose
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bacterial Infections Systemic Inflammatory Response Syndrome Anti-Infective Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action Bacteremia Enzyme Inhibitors Infection Pharmacologic Actions Inflammation |
Protein Synthesis Inhibitors Anti-Bacterial Agents Gram-Positive Bacterial Infections Sepsis Pathologic Processes Cefazolin Therapeutic Uses Vancomycin Linezolid |