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


Phase 3
18 Years
N/A
Not Enrolling
Both
Streptococcal Sepsis, Hematologic Malignancies

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Principal Investigator

Susan Seo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-142

NCT ID:

NCT00138112

Start Date:

November 2003

Completion Date:

November 2005

Related Keywords:

  • Streptococcal Sepsis
  • Hematologic Malignancies
  • Streptococcal Sepsis
  • Hematopoietic Stem Cell Transplantation
  • Hematologic Malignancies
  • Streptococci
  • Transplant
  • Neoplasms
  • Sepsis
  • Toxemia
  • Streptococcal Infections
  • Bacteremia
  • Hematologic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021