Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

• Status: Completed
• Trial end date: 2021-09-10
• Target enrollment: 0
• Participant gender: All

Summary

Primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. It will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

1. Allogeneic HSCT recipients between the ages of 2 and 21 years.

2. Underlying hematologic malignancy, regardless of donor type or graft source.

3. Myeloablative conditioning regimen.

Exclusion Criteria:

1. Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.

2. 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.

3. Patients with ongoing bacterial, viral or fungal active infections are not eligible for this study. Patients who remain on broad spectrum antibiotics for the treatment of a previous infection are not eligible.

4. The use of prophylactic antibiotics is not permitted.

5. Following the standard practice in blood and marrow transplantation, pregnant or breast feeding patients will be excluded