Clinical Trial: Randomized Trial of Prophylactic Vs Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation

This study is currently recruiting patients.
Verified by Memorial Sloan-Kettering Cancer Center August 2005

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00138112

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 bone marrow transplant. The other half will get it as soon as they have the first fever.

Streptococci are bacteria that live in our 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 bone marrow transplant very sick. All patients who get this infection are treated with antibiotics. Vancomycin is one drug 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 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
Hematopoietic Stem Cell Transplantation
Hematologic Malignancies
 Drug: EMPIRICAL VANCOMYCIN
 Drug: PROPHYLACTIC VANCOMYCIN
Phase III

MedlinePlus related topics:  Bacterial Infections;   Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapies;   Sepsis;   Streptococcal Infections;   Throat Disorders

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: 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.
Secondary Outcomes: 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.
Expected Total Enrollment:  126

Study start: November 2003
Last follow-up: August 2005

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 above,  Genders Eligible for Study:  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 IRB Informed Consent, including the Research Authorization component of the informed consent form.

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00138112

Susan Seo, MD      212-639-3151 

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Susan Seo, MD  212-639-3151 

Study chairs or principal investigators

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

More Information

Study ID Numbers:  03-142
Last Updated:  August 29, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00138112
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30

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