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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Streptococcal Sepsis Hematologic Malignancies

Keywords

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Streptococcal Sepsis Hematopoietic Stem Cell Transplantation Hematologic Malignancies Streptococci Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Empirical Vancomycin

Intervention Type DRUG

Prophylactic Vancomycin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Susan Seo, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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03-142

Identifier Type: -

Identifier Source: org_study_id