PMT for MDRO Decolonization

NCT05632315 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 852552
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Multidrug Resistant Bacterial Infection; Pseudomonas Aeruginosa; Enterobacteriaceae Infections; VRE Infection; Methicillin-resistant Staphylococcus Aureus

Outcome Measures

Primary Outcomes (5)

• Proportion 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.

  30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

• Frequency of solicited adverse events (AEs)

  randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

• Frequency of serious adverse events (SAEs)

  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)

  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)

  randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

Secondary Outcomes (13)

• Eradication of gut colonization with the index MDRO

  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

  7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

• All-cause mortality

  30- and 60-days following SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

• Colectomy occurrence

  within 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

• Cumulative days of hospitalization

  from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)

Study Arms (24)

ESCRE/CRE BL-BLI

EXPERIMENTAL

MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)

Drug: PMT

ESCRE/CRE BL-BLI standard of care (SOC)

NO INTERVENTION

MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)

ESCRE/CRE carbapenem +/- BLI

EXPERIMENTAL

MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI

Drug: PMT

ESCRE/CRE carbapenem +/- BLI standard of care (SOC)

NO INTERVENTION

MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI standard of care (SOC)

ESCRE/CRE Fluoroquinolone

EXPERIMENTAL

MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone

Drug: PMT

ESCRE/CRE Fluoroquinolone standard of care (SOC)

NO INTERVENTION

MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone standard of care (SOC)

MRSA lipo/glycopeptide

EXPERIMENTAL

MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide

Drug: PMT

MRSA lipo/glycopeptide standard of care (SOC)

NO INTERVENTION

MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide standard of care (SOC)

MRSA oxazolidinone

EXPERIMENTAL

MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone

Drug: PMT

MRSA oxazolidinone standard of care (SOC)

NO INTERVENTION

MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone standard of care (SOC)

MDR-PA BL-BLI

EXPERIMENTAL

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)

Drug: PMT

MDR-PA BL-BLI standard of care (SOC)

NO INTERVENTION

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)

MDR-PA carbapenem +/- BLI

EXPERIMENTAL

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI

Drug: PMT

MDR-PA carbapenem +/- BLI standard of care (SOC)

NO INTERVENTION

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC)

MDR-PA Fluoroquinolone

EXPERIMENTAL

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone

Drug: PMT

MDR-PA Fluoroquinolone standard of care (SOC)

NO INTERVENTION

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone standard of care (SOC)

VRE lipopeptide

EXPERIMENTAL

MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide

Drug: PMT

VRE lipopeptide standard of care (SOC)

NO INTERVENTION

MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC)

VRE oxazolidinone

EXPERIMENTAL

MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone

Drug: PMT

VRE oxazolidinone standard of care (SOC)

NO INTERVENTION

MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone standard of care (SOC)

ESCRE/CRE cefepime/cefidericol

EXPERIMENTAL

MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol

Drug: PMT

ESCRE/CRE cefepime/cefidericol standard of care (SOC)

NO INTERVENTION

MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol standard of care (SOC)

MDR-PA cefepime/cefidericol

EXPERIMENTAL

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol

Drug: PMT

MDR-PA cefepime/cefidericol standard of care (SOC)

NO INTERVENTION

MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol standard of care (SOC)

Interventions

PMT DRUG

Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)

Also known as: Penn Microbiome Therapy

ESCRE/CRE BL-BLI; ESCRE/CRE Fluoroquinolone; ESCRE/CRE carbapenem +/- BLI; ESCRE/CRE cefepime/cefidericol; MDR-PA BL-BLI; MDR-PA Fluoroquinolone; MDR-PA carbapenem +/- BLI; MDR-PA cefepime/cefidericol; MRSA lipo/glycopeptide; MRSA oxazolidinone; VRE lipopeptide; VRE oxazolidinone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (3)

Emory University - Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Enterobacteriaceae Infections; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Brendan J Kelly

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open label, comparative

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 30, 2022
• Study Start: August 19, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)