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PMT for MDRO Decolonization

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05632315
Collaborator
(none)
150
Enrollment
1
Location
20
Arms
36
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, open label, comparativeRandomized, open label, comparative
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: ESCRE/CRE BL-BLI

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

Drug: PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: 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)
    Experimental: ESCRE/CRE carbapenem +/- BLI

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

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: ESCRE/CRE carbapenem +/- BLI standard of care (SOC)

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

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

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: ESCRE/CRE Fluoroquinolone standard of care (SOC)

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

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

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: MRSA lipo/glycopeptide standard of care (SOC)

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

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

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: MRSA oxazolidinone standard of care (SOC)

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

    MDRO: two-class resistant Pseudomonas aeruginosa (PsA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: PsA BL-BLI standard of care (SOC)

    MDRO: two-class resistant Pseudomonas aeruginosa (PsA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
    Experimental: PsA carbapenem +/- BLI

    MDRO: two-class resistant Pseudomonas aeruginosa (PsA) Antibiotic Class: carbapenem +/- BLI

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: PsA carbapenem +/- BLI standard of care (SOC)

    MDRO: two-class resistant Pseudomonas aeruginosa (PsA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
    Experimental: PsA Fluoroquinolone

    MDRO: two-class resistant Pseudomonas aeruginosa (PsA) Antibiotic Class: Fluoroquinolone

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: PsA Fluoroquinolone standard of care (SOC)

    MDRO: two-class resistant Pseudomonas aeruginosa (PsA) Antibiotic Class: Fluoroquinolone standard of care (SOC)
    Experimental: VRE lipopeptide

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

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: VRE lipopeptide standard of care (SOC)

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

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

    Drug: PMT
    Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)
    Other Names:
  • Penn Microbiome Therapy

    		•
    No Intervention: VRE oxazolidinone standard of care (SOC)

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects with resolution of index MDRO colonization of the gut [30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate 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.

    2. Frequency of solicited adverse events (AEs) [180 days]

    3. Frequency of serious adverse events (SAEs) [180 days]

    4. Frequency of AEs of special interest (AESIs) [180 days]

    Secondary Outcome Measures

    1. Eradication of gut colonization with the index MDRO [7 days and 90 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

      i.e., negative selective bacterial culture for the index MDRO to be assessed in addition to primary endpoint

    2. Eradication of gut colonization with any of the included MDROs [7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

    3. All-cause mortality [30- and 60-days following SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

    4. Colectomy [within 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

    5. Cumulative days of hospitalization [from randomization to 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

    6. Cumulative days of intensive care [from randomization to 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

    7. Bacteremia [from randomization to 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)]

    8. Hospital admission [within 60 days of discharge from index hospitalization]

    9. Hospital admission [within 180 days after SCAIM]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 resistant 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 planned completion of antibiotic treatment for 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 (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.

    5. Known food allergy that could lead to anaphylaxis.

    6. Pregnancy or lactation a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT05632315
    Other Study ID Numbers:
    • FACE MDRO
    First Posted:
    Nov 30, 2022
    Last Update Posted:
    Nov 30, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Bacterial Infections
    Enterobacteriaceae Infections

    Study Results

    No Results Posted as of Nov 30, 2022