Rifaximin in Preventing Infections in Participants with Blood Cancer Undergoing Hematopoietic Stem Cell Transplantation

Active:	Yes
Cancer Type:	Hematopoietic Malignancies	NCT ID:	NCT03529825
Trial Phases:	Phase I	Protocol IDs:	CHOA4273-18 (primary) NCI-2018-00596 IRB00101158
Eligibility:	2 - 21 Years, Male and Female	Study Type:	Prevention
Study Sponsor:	Children's Healthcare of Atlanta - Egleston
NCI Full Details:	http://clinicaltrials.gov/show/NCT03529825

Summary

This pilot phase I trial studies how well rifaximin works in preventing infections and improving the balance of bacteria within the gut of participants with blood cancer who are undergoing blood and marrow transplantation. Rifaximin is an antibiotic used to treat intestinal infections by preventing bacteria from invading the intestinal wall. Giving rifaximin may help to prevent bacterial infections and improve transplant outcomes in participants undergoing hematopoietic stem cell transplantation.

Objectives

PRIMARY OBJECTIVE:
I. To describe the impact of rifaximin on gut microbiome diversity.

SECONDARY OBJECTIVE:
I. To estimate the rate of blood stream infections (BSI) in patients treated with rifaximin.

OUTLINE:
Participants receive rifaximin orally (PO) or enterally by gastric or naso-gastric/nasojejunal (NG/NJ) tube twice daily (BID) on day -7 or upon admittance to the hospital for hematopoietic stem cell transplantation (HSCT), whichever is later. Treatment continues for 28 days after HSCT or until discharge for a maximum of 36 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up on days 42 and 100, at 8 months, and at 1 year after HSCT.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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