Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

October 8, 2021 updated by: Muna Qayed, Emory University
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).

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin
Rifaximin will be administered twice a day orally or by nasogastric tube to patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alterations to microbiome diversity in children treated with rifaximin compared to the historical cohort.
Time Frame: 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.
Period between the start of the preparative regimen and day 28 post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of BSI pathogen infection/colonization frequency during the treatment period compared to the historical cohort.
Time Frame: 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.
Period between the start of the preparative regimen and day 28 post transplant
Transplant related mortality (TRM)
Time Frame: Period between the start of the preparative regimen and day 28 post transplant
Number of deaths occurring in continuous complete remission.
Period between the start of the preparative regimen and day 28 post transplant
Number of patients with Acute GVHD
Time Frame: 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
Period between the start of the preparative regimen and day 100 post transplant
Number of patients with Chronic GVHD including overlap syndrome
Time Frame: 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.
Period between the start of the preparative regimen and year 5 post-transplant.
Number of patients with other Infections
Time Frame: 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
Period between the start of the preparative regimen and day 28 post transplant
Number of patients with relapse free survival at 1 year
Time Frame: Period between the start of the preparative regimen and year 1 post-transplant.
Survival without relapse of underlying malignancy.
Period between the start of the preparative regimen and year 1 post-transplant.
Overall number of patients survived at 1 year
Time Frame: Period between the start of the preparative regimen and year 1 post-transplant.
Survival with or without relapse of underlying malignancy.
Period between the start of the preparative regimen and year 1 post-transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Muna Qayed, MD MSc, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

October 19, 2020

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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