Loading clinical trials...

PMT for MDRO Decolonization | Clinical Trials | Clareo Health

RECRUITINGPHASE2

PMT for MDRO Decolonization

A Phase II Randomized Trial to Evaluate the Impact of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products on Recipient and Environmental Colonization With Multidrug-Resistant Organisms

NCT05632315•University of Pennsylvania

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 non-susceptible 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 SCAIM (scheduled completion of inpatient appropriate antibiotics for the 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 or severe neutropenia within 10 calendar days prior to enrollment.
•5. Known food allergy that could lead to anaphylaxis.
•6. Known allergy to fecal microbiota transplant products or their components
•7. Pregnancy or lactation
•1. 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
•2. 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
+9 more criteria

Locations (3)

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

Key Dates

Start Date

August 19, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

October 21, 2025

Enrollment

150

ESTIMATED participants

Conditions

Multidrug Resistant Bacterial InfectionEnterobacteriaceae InfectionsPseudomonas AeruginosaVRE InfectionMethicillin-resistant Staphylococcus Aureus

Interventions

PMT

DRUG

Contacts

Brendan J Kelly, MD, MS

CONTACT

(215) 662-6932 brendank@pennmedicine.upenn.edu

Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

NCT06738771

Pseudomonas InfectionsPseudomonas Aeruginosa+4 more

View study

RECRUITINGPHASE1/PHASE2

Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

NCT06319235

Surgical Site InfectionStaphylococcus Aureus Infection+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PMT for MDRO Decolonization

Inclusion Criteria

Exclusion Criteria

Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

Animal-Assisted Visitation Program Chlorhexidine Trial

ANTIBIOTIC-RESISTANT ENTEROBACTERALES BLOODSTREAM INFECTIONS AND RISK FACTORS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT

Community-associated Highly-Resistant Enterobacterales

Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study