This is a randomized, open label, comparative Phase II trial being conducted to determine whether fecal microbiota transplant using Penn Microbiome Therapy (PMT) products helps standard therapy eradicate antibiotic-resistant bacteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
Emory University - Grady Memorial Hospital
Atlanta, Georgia, United States
NOT_YET_RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGProportion of subjects with resolution of index MDRO colonization of the gut
measured by selective stool culture, resolution will be defined as the absence of growth of the index MDRO on selective culture media.
Time frame: 30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of solicited adverse events (AEs)
Time frame: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of serious adverse events (SAEs)
Time frame: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of adverse events of special interest (AESIs)
Time frame: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of medically attended adverse events (MAAEs)
Time frame: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Eradication of gut colonization with the index MDRO
i.e., negative selective bacterial culture for the index MDRO to be assessed in addition to primary endpoint
Time frame: 7 days and 90 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Eradication of gut colonization with any of the included MDROs
Time frame: 7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
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All-cause mortality
Time frame: 30- and 60-days following SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Colectomy occurrence
Time frame: within 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Cumulative days of hospitalization
Time frame: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Cumulative days of intensive care
Time frame: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Bacteria growth in blood samples
Time frame: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Hospital admission
Time frame: within 60 days of discharge from index hospitalization
Hospital admission
Time frame: within 180 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Instances of worsened abdominal pain, fever, tachycardia, and hypotension
Time frame: randomization until 180-day visit
Instances of aspiration (including reduced oxygen saturation, tachypnea, or respiratory distress (PMT-002 upper entral delivery only)
Time frame: randomization until 180-day visit
Instances of fever, diarrhea, nausea and vomiting
Time frame: 7-, 30-, 90- and 180 day follow up visits
Instances of new metabolic disease, including hyperglycemia, thyroid disease, weight gain or loss
Time frame: 30-, 90- and 180 day follow up visits