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Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967096
First Posted: August 27, 2009
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Horan, Emory University
  Purpose
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.

Condition Intervention Phase
Malignancy Bone Marrow Transplantation Drug: Rifaximin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rifaximin for Preventing Acute Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by John Horan, Emory University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Rifaximin
Rifaximin for Bone marrow transplant patients

  Eligibility

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be at least 12 years old.
  2. 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.
  3. 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:

  1. Age under 12 years.
  2. Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.
  3. 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.
  4. Patients with documented severe active infection (viral, bacterial, fungal, protozoal) will not be eligible.
  5. Patients with treatment unresponsive hematologic malignant diseases (based on an assessment done within two weeks of the start of conditioning therapy).
  Contacts and Locations
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): NCT00967096


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: John Horan, MD Emory University
  More Information

Responsible Party: John Horan, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00967096     History of Changes
Other Study ID Numbers: IRB00003578
Rifaximin ( Other Identifier: Other )
First Submitted: August 11, 2009
First Posted: August 27, 2009
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by John Horan, Emory University:
rifaximin
acute graft versus host disease
bone marrow transplant
non-malignancy requiring BMT

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents