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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

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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