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Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT03529825
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Muna Qayed, Emory University

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).

Condition or disease Intervention/treatment Phase
Microbial Colonization Drug: Rifaximin Early Phase 1

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot, single arm prospective study with retrospective control arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


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).
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).

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529825


Contacts
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Contact: Chanta Whitlow, MPA, CCRP 404-785-0696 Chanta.Whitlow@choa.org

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Chanta Whitlow, MPA, CCRP    404-785-0696    chanta.whitlow@choa.org   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Muna Qayed, MD MSc Emory University

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Responsible Party: Muna Qayed, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03529825     History of Changes
Other Study ID Numbers: IRB00101158
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muna Qayed, Emory University:
Rifaximin
Microbiome
Allogeneic hematopoietic stem cell transplantation
Blood stream infections
Acute graft versus host disease

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents