FMT for MDRO Colonization in Solid Organ Transplant (NCT02816437) | Clinical Trial Compass
WithdrawnPhase 1
FMT for MDRO Colonization in Solid Organ Transplant
Stopped: safety
0Started 2016-07
Plain-language summary
This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Age ≥18 years old
* Solid organ transplant recipients: liver, intestinal, multivisceral transplants, heart, lung, pancreas or kidney transplant recipients
* Transplant recipient at least \>30 days post solid organ-transplant
* Transplant recipient must be available locally for follow up to 6-months post FMT transplant
* Inpatient status at time of FMT
* History of at least one or more treated infections in the last 90 days (bacteremia, UTI, pneumonia or abdominal collection with a positive culture with MDRO) due to an MDRO and the MDRO is likely of enteric origin (carbapenem resistant enterobacteriaceae (CRE), vancomycin resistant enterococci (VRE) or carbapenem resistant Pseudomonas (CRP).
* Be without active infection for \>15 days: bacteremia, UTI, pneumonia or abdominal collection.
* Be without a positive culture (except for stool) with MDRO (carbapenem resistant enterobacteriaceae (CRE), vancomycin resistant enterococci (VRE) or carbapenem resistant Pseudomonas (CRP)
* Patients are not receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT
* Solid organ prophylactic antimicrobials as per protocol will be held 24 hours before and 14 days post FMT e.g. trimethoprim/sulfamethoxazole 3x/week or dapsone 100 mg PO daily or weekly for PJP prophylaxis
* Ganciclovir or valgancyclovir for CMV prophylaxis if required as per protocol can be continued.
* Patients have a positive surveillance rectal culture for evidence of colonization.
Exc…