PMT for MDRO Decolonization (NCT05632315) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PMT for MDRO Decolonization
United States32 participantsStarted 2024-08-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Multidrug-resistant organism (MDRO) infection of the bloodstream, respiratory tract, or urinary tract. Qualifying MDROs include extended-spectrum cephalosporin-resistant Enterobacterales (ESCRE) or carbapenem-resistant Enterobacterales (CRE), Pseudomonas aeruginosa non-susceptible to two or more classes of antibiotics (MDR-PA), vancomycin-resistant Enterococcus (VRE), and methicillin-resistant Staphylococcus aureus (MRSA).
✓. On appropriate antibiotic treatment per clinical phenotypic susceptibility testing of the qualifying MDRO, and with a qualifying antibiotic class. Qualifying antibiotic classes include beta-lactam + beta-lactamase inhibitor, carbapenem (with or without betalactamase inhibitor), fluoroquinolone, lipopeptide, glycopeptide, or oxazolidinone.
✓. Expected duration of inpatient antibiotic treatment for index MDRO infection at least 5 days total.
✓. At least two calendar days remaining, and no more than 7 calendar days remaining prior to SCAIM (scheduled completion of inpatient appropriate antibiotics for the index MDRO infection).
✓. Age ≥ 18 years.
Exclusion criteria
✕. Evidence of colon/small bowel perforation at the time of study screening.
✕. Unable to tolerate enteral and enema nutrition and medication administration (i.e., only able to tolerate intravenous nutrition and medications).
✕. Goals of care are directed to comfort rather than curative measures.
✕. Moderate or severe neutropenia within 10 calendar days prior to enrollment.
What they're measuring
1
Proportion of subjects with resolution of index MDRO colonization of the gut
Timeframe: 30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
2
Frequency of solicited adverse events (AEs)
Timeframe: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
3
Frequency of serious adverse events (SAEs)
Timeframe: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
4
Frequency of adverse events of special interest (AESIs)
Timeframe: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
5
Frequency of medically attended adverse events (MAAEs)
Timeframe: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
. Known food allergy that could lead to anaphylaxis.
✕. Known allergy to fecal microbiota transplant products or their components
✕. Pregnancy or lactation
✕. For subjects of childbearing potential (ages 18 to 55) and who are randomized to receive the intervention, the subject must have a negative pregnancy test within 24 hours prior to product administration