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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00138112
First received: August 26, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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.


Condition Intervention Phase
Streptococcal Sepsis
Hematologic Malignancies
Drug: Empirical Vancomycin
Drug: Prophylactic Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Early Viridans Streptococcal Sepsis After Hematopoietic Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 126
Study Start Date: November 2003
Estimated Study Completion Date: November 2005
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138112

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Susan Seo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00138112     History of Changes
Other Study ID Numbers: 03-142
Study First Received: August 26, 2005
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Streptococcal Sepsis
Hematopoietic Stem Cell Transplantation
Hematologic Malignancies
Streptococci
Transplant

Additional relevant MeSH terms:
Neoplasms
Sepsis
Toxemia
Streptococcal Infections
Bacteremia
Hematologic Neoplasms
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Neoplasms by Site
Hematologic Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014