- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967096
Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)
November 26, 2013 updated by: John Horan, Emory University
Rifaximin for Preventing Acute Graft Versus Host Disease
Acute graft versus host disease is a frequent and often life threatening complication of allogeneic blood and marrow transplantation.
The bacteria that normally reside in the intestine play a critical role in its development.
Injury to the lining of the bowel that results from the high dose chemotherapy or radiation that transplant patients receive during the week preceding the transplant allows the bacteria to invade the intestines and spread to nearby lymph nodes.
This, in turn, causes inflammation which has been shown to promote GVHD.
Both pre-clinical and clinical research has demonstrated that oral antibiotics can prevent graft versus host disease by inhibiting these gut bacteria.
Rifaximin has several features that suggest it could be effective in preventing GVHD.
Rifaximin prophylaxis might also provide an added benefit by protecting highly immunocompromised transplant patients from severe bacterial infections.
This pilot trial will allow the investigators to determine the feasibility of using Rifaximin for prevention of GVHD and infection in patients undergoing allogeneic blood and marrow transplantation.
The preliminary results will be used to plan a more definitive trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, United States, 30322
- Emory University
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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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must be at least 12 years old.
- Patients will be eligible regardless of their type of disease (malignant or non-malignant), type of donor (HLA matched related, mismatched related or unrelated donors), type of hematopoietic cell source (unstimulated marrow, cytokine stimulated marrow, cytokine stimulated peripheral blood or umbilical cord blood), or GVHD prophylaxis.
- Patients must receive a myeloablative or moderately intensive reduced intensity (at least 8 mg/kg oral busulfan (or the equivalent IV dose), or at least 100 mg/m2 of Melphalan , or at least 100 mg/kg of cyclophosphamide, or at least 500 cGy of TBI) conditioning regimen.
Exclusion Criteria:
- Age under 12 years.
- 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 documented severe active infection (viral, bacterial, fungal, protozoal) will not be eligible.
- Patients with treatment unresponsive hematologic malignant diseases (based on an assessment done within two weeks of the start of conditioning therapy).
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: 1
The primary clinical endpoint to be assessed in this study will be the proportion of Rifaximin doses successfully administered.
Because of mucositis, compliance with oral agents, even those that are well tolerated in other settings, may be limited in the early post-transplant period.
Thus, it will be important to demonstrate the feasibility of administering Rifaximin to BMT patients before embarking on larger scale studies.
Secondary outcomes will include AGVHD, event-free survival, overall survival, non-relapse mortality, neutrophil and platelet engraftment.
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Rifaximin for Bone marrow transplant patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the feasibility of this approach; to gather preliminary data on the incidence of GVHD and other clinical outcomes; to obtain pre-clinical data on the serial plasma levels of three biologic markers- endotoxin, soluble IL-2 receptor and TNF.
Time Frame: 1 year after last patient enrolled
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1 year after last patient enrolled
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Obtain preliminary data on the efficacy of administering rifaximin for prophylaxis against serious bacterial infections in BMT patients.
Time Frame: 1 year after last patient enrolled
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1 year after last patient enrolled
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Horan, MD, 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
April 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
August 11, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (Estimate)
August 27, 2009
Study Record Updates
Last Update Posted (Estimate)
November 27, 2013
Last Update Submitted That Met QC Criteria
November 26, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00003578
- Rifaximin (Other Identifier: Other)
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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