Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation
- Registration Number
- NCT03529825
- Lead Sponsor
- Emory University
- Brief 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).
- Detailed Description
This study is for patients who will be having a blood/marrow transplant (BMT) to treat leukemia, lymphoma or other cancer of the blood. The blood or marrow cells will come from another person (donor)-allogeneic BMT. Bacterial infections and acute graft versus host disease (AGVHD) are frequent complications of allogeneic BMT. Bacterial infections sometimes happen because injury to the gut during transplant allows gut bacteria to cross the injured gut barrier and get to the blood. AGVHD happens when certain white blood cells, called T-cells, in the donor cells (the graft) attack the patient's body.
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Allogeneic HSCT recipients between the ages of 2 and 21 years.
- Underlying hematologic malignancy, regardless of donor type or graft source.
- Myeloablative conditioning regimen.
- 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 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.
- The use of prophylactic antibiotics is not permitted.
- Following the standard practice in blood and marrow transplantation, pregnant or breast feeding patients will be excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rifaximin Rifaximin Rifaximin will be administered twice a day orally or by nasogastric tube to patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
- Primary Outcome Measures
Name Time Method Alterations to microbiome diversity in children treated with rifaximin compared to the historical cohort. Period between the start of the preparative regimen and day 28 post transplant Composition will be assessed using 16S RNA sequencing. The Shannon index will be calculated for quantification of bacterial diversity.
- Secondary Outcome Measures
Name Time Method Number of patients with Acute GVHD Period between the start of the preparative regimen and day 100 post transplant Early onset (before day 100) acute GVHD (including all grades, and stratified by grades) will be assessed according to the Blood and Marrow Transplant Clinical Trials Network Manual version 2, 2005, section 1 using the NIH consensus criteria
Number of patients with Chronic GVHD including overlap syndrome Period between the start of the preparative regimen and year 5 post-transplant. Chronic GVHD including overlap syndrome, will be assessed according to the 2014 NIH consensus criteria.
Number of patients with other Infections Period between the start of the preparative regimen and day 28 post transplant Other Infections will be defined in accordance with the Blood and Marrow Transplant Clinical Trials Network Manual of Procedures
Number of patients with relapse free survival at 1 year Period between the start of the preparative regimen and year 1 post-transplant. Survival without relapse of underlying malignancy.
Overall number of patients survived at 1 year Period between the start of the preparative regimen and year 1 post-transplant. Survival with or without relapse of underlying malignancy.
Rates of BSI pathogen infection/colonization frequency during the treatment period compared to the historical cohort. Period between the start of the preparative regimen and day 28 post transplant Results of the GI pathogen panel, a test incorporated into routine patient care detecting DNA or RNA of 22 common viral, bacterial, and parasitic organisms, will provide a second assessment through molecular detection of the presence of common organisms associated with intestinal dysbiosis.
Transplant related mortality (TRM) Period between the start of the preparative regimen and day 28 post transplant Number of deaths occurring in continuous complete remission.
Trial Locations
- Locations (1)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States