PMT for MDRO Decolonization
Running, not enrolling · Phase 2
Conditions studied: Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections, Pseudomonas Aeruginosa, VRE Infection, Methicillin-resistant Staphylococcus Aureus
In brief
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.
Key facts
- Study ID
- NCT05632315
- Run by
- University of Pennsylvania
- People needed
- 32
- Starts
- 2024-08-19
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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
- Female or male subjects (ages 18 to 55) of reproductive potential engaged in active sexual activity that could lead to a pregnancy must agree to use one of the following forms of birth control while receiving study medications and through day 28 following completion of treatment, at minimum:
- i. Male or female condoms
- ii. Diaphragm or cervical cap with spermicide, if available
- iii. Intrauterine device (IUD)
- iv. Oral contraceptives or other hormonal contraception
- Known gastrointestinal disease that could affect the safety of fecal microbiota transplant at time of enrollment:
- Inflammatory Bowel Disease (IBD)
- Short Gut Syndrome
- Fistulas
- Bowel resection surgery
- Colitis
Where it is running
- Emory University - Grady Memorial Hospital — Atlanta, Georgia, United States
- Washington University — St Louis, Missouri, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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