Status:
COMPLETED
Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Streptococcal Sepsis
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will ...
Detailed Description
The primary objective of this study is as follows: * To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic ...
Eligibility Criteria
Inclusion
- Adult patients undergoing allogeneic HSCT for hematologic malignancies or other disorders
- Conditioning regimen that includes high-dose total body irradiation (TBI) (\>1200 cGy)
- The ability to understand and the willingness to sign the Institutional Review Board (IRB)-approved Informed Consent, including the Research Authorization component of the Informed Consent form.
Exclusion
- Non-TBI conditioning regimen
- Prior history of hypersensitivity to vancomycin (excluding history of "Red Man Syndrome")
- Fever or infection that requires intravenous vancomycin or oral/intravenous linezolid between day-7 and day-3 before hematopoietic stem cell transplant
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00138112
Start Date
November 1 2003
End Date
November 1 2005
Last Update
September 8 2006
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021