Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-08-19
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ESCRE/CRE BL-BLI
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
ESCRE/CRE BL-BLI standard of care (SOC)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
No interventions assigned to this group
ESCRE/CRE carbapenem +/- BLI
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
ESCRE/CRE carbapenem +/- BLI standard of care (SOC)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
No interventions assigned to this group
ESCRE/CRE Fluoroquinolone
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
ESCRE/CRE Fluoroquinolone standard of care (SOC)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone standard of care (SOC)
No interventions assigned to this group
MRSA lipo/glycopeptide
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
MRSA lipo/glycopeptide standard of care (SOC)
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide standard of care (SOC)
No interventions assigned to this group
MRSA oxazolidinone
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
MRSA oxazolidinone standard of care (SOC)
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone standard of care (SOC)
No interventions assigned to this group
MDR-PA BL-BLI
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
MDR-PA BL-BLI standard of care (SOC)
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
No interventions assigned to this group
MDR-PA carbapenem +/- BLI
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
MDR-PA carbapenem +/- BLI standard of care (SOC)
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
No interventions assigned to this group
MDR-PA Fluoroquinolone
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
MDR-PA Fluoroquinolone standard of care (SOC)
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone standard of care (SOC)
No interventions assigned to this group
VRE lipopeptide
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
VRE lipopeptide standard of care (SOC)
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC)
No interventions assigned to this group
VRE oxazolidinone
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
VRE oxazolidinone standard of care (SOC)
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone standard of care (SOC)
No interventions assigned to this group
ESCRE/CRE cefepime/cefidericol
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
ESCRE/CRE cefepime/cefidericol standard of care (SOC)
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol standard of care (SOC)
No interventions assigned to this group
MDR-PA cefepime/cefidericol
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol
PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
MDR-PA cefepime/cefidericol standard of care (SOC)
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol standard of care (SOC)
No interventions assigned to this group
Interventions
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PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
ii. Diaphragm or cervical cap with spermicide, if available
iii. Intrauterine device (IUD)
iv. Oral contraceptives or other hormonal contraception
8. Known gastrointestinal disease that could affect the safety of fecal microbiota transplant at time of enrollment:
1. Inflammatory Bowel Disease (IBD)
2. Short Gut Syndrome
3. Fistulas
4. Bowel resection surgery
5. Colitis
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Brendan J Kelly
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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852552
Identifier Type: -
Identifier Source: org_study_id
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