Multidrug Resistant Bacterial InfectionPhase 2NCT05632315
PMT for MDRO Decolonization
A Phase 2 study testing PMT in people with Multidrug Resistant Bacterial Infection and Enterobacteriaceae Infections, run by University of Pennsylvania at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections, Pseudomonas Aeruginosa
- What is being tested?
- PMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Aug 2024to 24 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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:
- Male or female condoms
- Diaphragm or cervical cap with spermicide, if available
- Intrauterine device (IUD)
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Emory University - Grady Memorial Hospital
Atlanta, Georgia, 30303
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University
St Louis, Missouri, 63110
About this study
Official title: 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
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, Enterobacteriaceae Infections, Pseudomonas Aeruginosa, VRE Infection, Methicillin-resistant Staphylococcus Aureus
- Being tested
- PMT
- Medical subject headings
- Enterobacteriaceae Infections, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMTDrug
Also called Penn Microbiome Therapy
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
| Study group | Role | What they receive |
|---|---|---|
| ESCRE/CRE BL-BLI | Experimental | MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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) Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of solicited adverse events (AEs)
Measured: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of serious adverse events (SAEs)
Measured: 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)
Measured: 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)
Measured: 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
i.e., negative selective bacterial culture for the index MDRO to be assessed in addition to primary endpoint
Measured: 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
Measured: 7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
All-cause mortality
Measured: 30- and 60-days following SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Colectomy occurrence
Measured: within 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Cumulative days of hospitalization
Measured: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Cumulative days of intensive care
Measured: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Bacteria growth in blood samples
Measured: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Hospital admission
Measured: within 60 days of discharge from index hospitalization
Hospital admission
Measured: within 180 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Instances of worsened abdominal pain, fever, tachycardia, and hypotension
Measured: randomization until 180-day visit
Instances of aspiration (including reduced oxygen saturation, tachypnea, or respiratory distress (PMT-002 upper entral delivery only)
Measured: randomization until 180-day visit
Instances of fever, diarrhea, nausea and vomiting
Measured: 7-, 30-, 90- and 180 day follow up visits
Instances of new metabolic disease, including hyperglycemia, thyroid disease, weight gain or loss
Measured: 30-, 90- and 180 day follow up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start19 Aug 2024
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistant Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label, comparative
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan J Kelly, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632315
- Sponsor's protocol ID
- 852552
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05632315
- Acronym / sponsor ID
- 852552
- Conditions
- Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections, Pseudomonas Aeruginosa, VRE Infection, Methicillin-resistant Staphylococcus Aureus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 24
- Model description
- Randomized, open label, comparative
| Arm | Type | Receives |
|---|---|---|
| ESCRE/CRE BL-BLI | Experimental | Drug: PMTMDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) |
| 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 | Drug: PMTMDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI |
| 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 | Drug: PMTMDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone |
| 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 | Drug: PMTMRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide |
| 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 | Drug: PMTMRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone |
| 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 | Drug: PMTMDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) |
| 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 | Drug: PMTMDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI |
| 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 | Drug: PMTMDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone |
| 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 | Drug: PMTMDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide |
| VRE lipopeptide standard of care (SOC) | No intervention | –MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC) |
| VRE oxazolidinone | Experimental | Drug: PMTMDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone |
| 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 | Drug: PMTMDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol |
| 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 | Drug: PMTMDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMTAlso: Penn Microbiome TherapyFecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002) | Drug | 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 |
Primary outcome
Proportion of subjects with resolution of index MDRO colonization of the gut
Time frame: 30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
measured by selective stool culture, resolution will be defined as the absence of growth of the index MDRO on selective culture media.
Frequency of solicited adverse events (AEs)
Time frame: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Frequency of serious adverse events (SAEs)
Time frame: 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)
Time frame: 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)
Time frame: randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
13 secondary outcomes
Eradication of gut colonization with the index MDRO
Time frame: 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
Time frame: 7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
All-cause mortality
Time frame: 30- and 60-days following SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Colectomy occurrence
Time frame: within 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Cumulative days of hospitalization
Time frame: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Cumulative days of intensive care
Time frame: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Bacteria growth in blood samples
Time frame: from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Hospital admission
Time frame: within 60 days of discharge from index hospitalization
Hospital admission
Time frame: within 180 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)
Instances of worsened abdominal pain, fever, tachycardia, and hypotension
Time frame: randomization until 180-day visit
Instances of aspiration (including reduced oxygen saturation, tachypnea, or respiratory distress (PMT-002 upper entral delivery only)
Time frame: randomization until 180-day visit
Instances of fever, diarrhea, nausea and vomiting
Time frame: 7-, 30-, 90- and 180 day follow up visits
Instances of new metabolic disease, including hyperglycemia, thyroid disease, weight gain or loss
Time frame: 30-, 90- and 180 day follow up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan J Kelly principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PMT in people with Multidrug Resistant Bacterial Infection and Enterobacteriaceae Infections, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with resolution of index MDRO colonization of the gut (time frame: 30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.