A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections
13 Years
N/A
Both
Febrile Neutropenia
Trial Information
A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections
Inclusion Criteria:
Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).
Patients must have a cancer with recent chemotherapy and risks factors for gram positive
infections.
Exclusion Criteria:
Patients with fever due to known causes. Patients with HIV. Patients with recent bone
marrow transplant. Patients with an infected indwelling catheter that cannot be removed.
Patients who have received more than one day of another antibiotic before entering the
trial.
Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
Outcome Time Frame:
7-28 days
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
M12600079
NCT ID:
NCT00035425
Start Date:
November 2001
Completion Date:
November 2002
Related Keywords:
- Febrile Neutropenia
- Fever
- Neutropenia
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
