Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation
Information source: Memorial Sloan-Kettering Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Streptococcal Sepsis; Hematologic Malignancies
Intervention: Empirical Vancomycin (Drug); Prophylactic Vancomycin (Drug)
Phase: Phase 3
Sponsored by: Memorial Sloan-Kettering Cancer Center
Official(s) and/or principal investigator(s):
Susan Seo, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center
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 get it as soon as they have the first fever.
Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into
the blood when the lining of the mouth and gut weakens from cancer therapy. This can make
the person who is undergoing a bone marrow transplant very sick. All patients who get this
infection are treated with antibiotics. Vancomycin is one drug that is used to treat this
bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before
a bone marrow transplant seems to prevent this infection. However, giving vancomycin too
soon may increase the chance that the kidneys will be irritated. It may also increase the
chance that other bacteria will become resistant to this drug. We, the investigators at
Memorial Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the
patient has a first fever can also prevent this infection.
Official title: Randomized Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Early Viridans Streptococcal Sepsis After Hematopoietic Cell Transplantation
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients
To examine the safety and tolerability for each vancomycin administration approach
To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for patients managed with each of the two vancomycin administration approaches
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 stem cell transplant
The secondary objectives of the study are:
- To examine the safety and tolerability for each vancomycin administration approach.
- To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for
patients managed with each of the two vancomycin administration approaches.
Minimum age: 18 Years.
Maximum age: N/A.
- Adult patients undergoing allogeneic HSCT for hematologic malignancies or other
- 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.
- Non-TBI conditioning regimen
- Prior history of hypersensitivity to vancomycin (excluding history of “Red Man
- Fever or infection that requires intravenous vancomycin or oral/intravenous linezolid
between day-7 and day-3 before hematopoietic stem cell transplant
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Memorial Sloan-Kettering Cancer Center
Starting date: November 2003
Ending date: November 2005
Last updated: September 7, 2006