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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

August 26, 2005
September 7, 2006
November 2003
Not Provided
To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients
  • -•To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients.
  • The primary objective of this study is as follows:
Complete list of historical versions of study NCT00138112 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
Not Provided
 
Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation
Randomized Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Early Viridans Streptococcal Sepsis After Hematopoietic Cell Transplantation

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Streptococcal Sepsis
  • Hematologic Malignancies
  • Drug: Empirical Vancomycin
  • Drug: Prophylactic Vancomycin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
November 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00138112
03-142
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Susan Seo, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP