Status:
COMPLETED
Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)
Lead Sponsor:
Emory University
Conditions:
Malignancy
Bone Marrow Transplantation
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
Acute graft versus host disease is a frequent and often life threatening complication of allogeneic blood and marrow transplantation. The bacteria that normally reside in the intestine play a critical...
Eligibility Criteria
Inclusion
- Patients must be at least 12 years old.
- Patients will be eligible regardless of their type of disease (malignant or non-malignant), type of donor (HLA matched related, mismatched related or unrelated donors), type of hematopoietic cell source (unstimulated marrow, cytokine stimulated marrow, cytokine stimulated peripheral blood or umbilical cord blood), or GVHD prophylaxis.
- Patients must receive a myeloablative or moderately intensive reduced intensity (at least 8 mg/kg oral busulfan (or the equivalent IV dose), or at least 100 mg/m2 of Melphalan , or at least 100 mg/kg of cyclophosphamide, or at least 500 cGy of TBI) conditioning regimen.
Exclusion
- Age under 12 years.
- Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.
- Minimally toxic conditioning regimen (e.g. low dose TBI based). Since these regimens induce minimal myelosuppression and gut injury, patients receiving them probably stand little to gain from antibiotic prophylaxis.
- Patients with documented severe active infection (viral, bacterial, fungal, protozoal) will not be eligible.
- Patients with treatment unresponsive hematologic malignant diseases (based on an assessment done within two weeks of the start of conditioning therapy).
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00967096
Start Date
April 1 2007
End Date
April 1 2009
Last Update
November 27 2013
Active Locations (2)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
Emory University
Atlanta, Georgia, United States, 30322