Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

Microbial Colonization Clinical Trial

Official title:

Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529825
• Other study ID #: IRB00101158
• Status: Completed
• Phase: Early Phase 1
• Start date: July 18, 2018
• Est. completion date: September 10, 2021

Study information

• Verified date: October 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 10, 2021
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

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