Status:
WITHDRAWN
Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft-versus-host Disease Prevention
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibio...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the proportion of patients who develop acute graft-versus-host disease (GVHD) of the gastrointestinal (GI) tract by day 100 post-transplant for patients randomized ...
Eligibility Criteria
Inclusion
- Patients who are day -10 pre- to day +30 post-allogeneic hematopoietic cell transplant (AHCT) from any donor or graft source and for any conditioning regimen
- Patients who have received treatment with meropenem or piperacillin-tazobactam (pip-tazo) intravenously (IV) (of at least 24 hours duration) in past 7 days
- Controlled infection defined as hemodynamically stable and not requiring supplemental oxygen of more than 2 liters via nasal cannula
- Patients who are able to take oral medications in suspension form
- Patients who are able to provide informed consent (IC) and comply with all study visits and procedures
Exclusion
- Patients who are anticipated to require continued broad spectrum antibiotics with meropenem or pip-tazo IV for \> 96 hours post-engraftment such as for known, documented infections necessitating prolonged treatment
- Patients with a prior documented infection with mycormycetes
- Patients who are greater than 2 days from time of neutrophil engraftment post AHCT
- Patients with active enteric infections
- Patients with acute GVHD \>= grade II
- Patients unwilling or unable to undergo the FMT via retention enema procedure
- Patients who have received treatment with an investigational agent within 2 weeks of enrollment
- Patients unable to tolerate oral decontamination regimen of pip-tazo and nystatin due to prior allergy or intolerance of these medications
- Patients with any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, pose any additional risk for the subject, or confound the assessments of the subject
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03862079
Start Date
June 1 2020
End Date
December 31 2021
Last Update
March 4 2020
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030