Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation

Condition(s) targeted: Streptococcal Sepsis; Hematologic Malignancies

Intervention: Empirical Vancomycin (Drug); Prophylactic Vancomycin (Drug)

Phase: Phase 3

Status: Completed

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

Secondary outcome:

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

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 stem cell transplant (HSCT) patients.

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

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