Overview

PMT for MDRO Decolonization

Status:
Not yet recruiting

Trial end date:
2026-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Pennsylvania

Criteria

Inclusion Criteria:

1. 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 resistant to two or more classes of antibiotics (MDR-PA),
vancomycin-resistant Enterococcus (VRE), and methicillin-resistant Staphylococcus
aureus (MRSA).

2. 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.

3. Expected duration of inpatient antibiotic treatment for index MDRO infection at least
5 days total.

4. At least two calendar days remaining, and no more than 7 calendar days remaining prior
to planned completion of antibiotic treatment for index MDRO infection.

5. Age ≥ 18 years.

Exclusion Criteria:

1. Evidence of colon/small bowel perforation at the time of study screening.

2. Unable to tolerate enteral and enema nutrition and medication administration (i.e.,
only able to tolerate intravenous nutrition and medications).

3. Goals of care are directed to comfort rather than curative measures.

4. Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.

5. Known food allergy that could lead to anaphylaxis.

6. Pregnancy or lactation a. For subjects of childbearing potential (ages 18 to 55), the
subject must have a negative urine pregnancy test within 48 hours of consent and no
more than 48 hours prior to first product administration