PMT for MDRO Decolonization
Status and phase
Enrolling
Phase 2
Conditions
Methicillin-resistant Staphylococcus Aureus
Enterobacteriaceae Infections
VRE Infection
Multidrug Resistant Bacterial Infection
Pseudomonas Aeruginosa
Treatments
Drug: PMT
Details and patient eligibility
About
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.
Enrollment
150 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
-
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
150 participants in 24 patient groups
ESCRE/CRE BL-BLI
Experimental group
Description:
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
Treatment:
Drug: PMT
ESCRE/CRE BL-BLI standard of care (SOC)
No Intervention group
Description:
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
ESCRE/CRE carbapenem +/- BLI
Experimental group
Description:
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI
Treatment:
Drug: PMT
ESCRE/CRE carbapenem +/- BLI standard of care (SOC)
No Intervention group
Description:
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
ESCRE/CRE Fluoroquinolone
Experimental group
Description:
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone
Treatment:
Drug: PMT
ESCRE/CRE Fluoroquinolone standard of care (SOC)
No Intervention group
Description:
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone standard of care (SOC)
MRSA lipo/glycopeptide
Experimental group
Description:
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide
Treatment:
Drug: PMT
MRSA lipo/glycopeptide standard of care (SOC)
No Intervention group
Description:
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide standard of care (SOC)
MRSA oxazolidinone
Experimental group
Description:
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone
Treatment:
Drug: PMT
MRSA oxazolidinone standard of care (SOC)
No Intervention group
Description:
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone standard of care (SOC)
MDR-PA BL-BLI
Experimental group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
Treatment:
Drug: PMT
MDR-PA BL-BLI standard of care (SOC)
No Intervention group
Description:
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 group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI
Treatment:
Drug: PMT
MDR-PA carbapenem +/- BLI standard of care (SOC)
No Intervention group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
MDR-PA Fluoroquinolone
Experimental group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone
Treatment:
Drug: PMT
MDR-PA Fluoroquinolone standard of care (SOC)
No Intervention group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone standard of care (SOC)
VRE lipopeptide
Experimental group
Description:
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide
Treatment:
Drug: PMT
VRE lipopeptide standard of care (SOC)
No Intervention group
Description:
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC)
VRE oxazolidinone
Experimental group
Description:
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone
Treatment:
Drug: PMT
VRE oxazolidinone standard of care (SOC)
No Intervention group
Description:
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone standard of care (SOC)
ESCRE/CRE cefepime/cefidericol
Experimental group
Description:
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol
Treatment:
Drug: PMT
ESCRE/CRE cefepime/cefidericol standard of care (SOC)
No Intervention group
Description:
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol standard of care (SOC)
MDR-PA cefepime/cefidericol
Experimental group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol
Treatment:
Drug: PMT
MDR-PA cefepime/cefidericol standard of care (SOC)
No Intervention group
Description:
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol standard of care (SOC)
Trial contacts and locations
1
Loading...
Central trial contact
Brendan J Kelly, MD, MS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems