Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

03-142


NCT ID:

NCT00138112


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

126


Enrollment Type:


Overall Contact Information

Official Name:Susan Seo, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:November 2003
Completion Date:November 2005
Verification Date:September 2006
Last Changed Date:September 7, 2006
First Received Date:August 26, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for patients managed with each of the two vancomycin administration approaches
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To examine the safety and tolerability for each vancomycin administration approach
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Empirical Vancomycin
Intervention Type:Drug
Name:Prophylactic Vancomycin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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