Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

NCT ID: NCT03529825

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2021-09-10

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).

Conditions

Microbial Colonization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rifaximin

Rifaximin will be administered twice a day orally or by nasogastric tube to patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).

Group Type: EXPERIMENTAL

Rifaximin

Intervention Type: DRUG

Rifaximin will be administered twice a day orally or by nasogastric tube, at a dose of 15 mg/kg divided BID with a maximum dose of 1,650 mg, day -7 to day +28 or discharge (maximum duration 36 days).

Retrospective comparison cohort

Thirty six patients who underwent HSCT for hematologic malignancies, and received myeloablative conditioning, without prophylactic antibiotics, between 2013-2017 enrolled in the Aflac biorepository will comprise the comparison arm. Clinical data on transplant and infection characteristics is available and linked to stool microbiome samples already analyzed and described. Stored plasma and peripheral blood mononuclear cells are available for further analysis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rifaximin

Rifaximin will be administered twice a day orally or by nasogastric tube, at a dose of 15 mg/kg divided BID with a maximum dose of 1,650 mg, day -7 to day +28 or discharge (maximum duration 36 days).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Muna Qayed

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muna Qayed, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00101158

Identifier Type: -

Identifier Source: org_study_id