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Completed

NCT Number: NCT03529825

Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

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).

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Allogeneic HSCT recipients between the ages of 2 and 21 years.
  • Underlying hematologic malignancy, regardless of donor type or graft source.
  • Myeloablative conditioning regimen.

Exclusion criteria

  • 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

Treatment and study plan

Rifaximin

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 18, 2018
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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