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Microbiome Therapy

Phage Therapy for MDRO Decolonization

Phase 2
Recruiting
Led By Brendan J Kelly
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days and 90 days after scaim (scheduled completion of appropriate inpatient antibiotics for the index mdro infection)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new treatment using bacteria from poop can help get rid of bacteria that don't respond to antibiotics.

Who is the study for?
This trial is for adults over 18 with certain drug-resistant infections (like MRSA, VRE, or resistant Pseudomonas) who are on specific antibiotics. They must have a few days left of treatment and not be allergic to fecal microbiota transplant products. Pregnant women can't join, and participants must use birth control if they can have children.
What is being tested?
The study tests if Penn Microbiome Therapy (PMT), a type of fecal microbiota transplant, helps standard antibiotic therapy get rid of tough-to-treat bacteria better than antibiotics alone in patients with serious infections.
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions related to the body's acceptance of the transplanted microbiota such as gastrointestinal discomfort, bloating, diarrhea or constipation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days and 90 days after scaim (scheduled completion of appropriate inpatient antibiotics for the index mdro infection)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days and 90 days after scaim (scheduled completion of appropriate inpatient antibiotics for the index mdro infection) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects with resolution of index MDRO colonization of the gut
Secondary study objectives
Eradication of gut colonization with the index MDRO

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

24Treatment groups
Experimental Treatment
Active Control
Group I: VRE oxazolidinoneExperimental Treatment1 Intervention
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone
Group II: VRE lipopeptideExperimental Treatment1 Intervention
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide
Group III: MRSA oxazolidinoneExperimental Treatment1 Intervention
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone
Group IV: MRSA lipo/glycopeptideExperimental Treatment1 Intervention
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide
Group V: MDR-PA cefepime/cefidericolExperimental Treatment1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol
Group VI: MDR-PA carbapenem +/- BLIExperimental Treatment1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI
Group VII: MDR-PA FluoroquinoloneExperimental Treatment1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone
Group VIII: MDR-PA BL-BLIExperimental Treatment1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
Group IX: ESCRE/CRE cefepime/cefidericolExperimental Treatment1 Intervention
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol
Group X: ESCRE/CRE carbapenem +/- BLIExperimental Treatment1 Intervention
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI
Group XI: ESCRE/CRE FluoroquinoloneExperimental Treatment1 Intervention
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone
Group XII: ESCRE/CRE BL-BLIExperimental Treatment1 Intervention
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
Group XIII: ESCRE/CRE Fluoroquinolone standard of care (SOC)Active Control1 Intervention
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone standard of care (SOC)
Group XIV: MRSA lipo/glycopeptide standard of care (SOC)Active Control1 Intervention
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide standard of care (SOC)
Group XV: MRSA oxazolidinone standard of care (SOC)Active Control1 Intervention
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone standard of care (SOC)
Group XVI: ESCRE/CRE BL-BLI standard of care (SOC)Active Control1 Intervention
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
Group XVII: MDR-PA cefepime/cefidericol standard of care (SOC)Active Control1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol standard of care (SOC)
Group XVIII: MDR-PA BL-BLI standard of care (SOC)Active Control1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
Group XIX: MDR-PA carbapenem +/- BLI standard of care (SOC)Active Control1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
Group XX: ESCRE/CRE carbapenem +/- BLI standard of care (SOC)Active Control1 Intervention
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
Group XXI: VRE oxazolidinone standard of care (SOC)Active Control1 Intervention
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone standard of care (SOC)
Group XXII: VRE lipopeptide standard of care (SOC)Active Control1 Intervention
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC)
Group XXIII: MDR-PA Fluoroquinolone standard of care (SOC)Active Control1 Intervention
MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone standard of care (SOC)
Group XXIV: ESCRE/CRE cefepime/cefidericol standard of care (SOC)Active Control1 Intervention
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol standard of care (SOC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PMT
2008
N/A
~660

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,078 Previous Clinical Trials
42,721,235 Total Patients Enrolled
Brendan J KellyPrincipal InvestigatorUniversity of Pennsylvania

Media Library

PMT (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05632315 — Phase 2
Enterobacterial Infection Research Study Groups: ESCRE/CRE Fluoroquinolone standard of care (SOC), MRSA lipo/glycopeptide standard of care (SOC), MRSA oxazolidinone standard of care (SOC), ESCRE/CRE BL-BLI standard of care (SOC), ESCRE/CRE carbapenem +/- BLI, MDR-PA cefepime/cefidericol standard of care (SOC), MDR-PA Fluoroquinolone, MRSA lipo/glycopeptide, MRSA oxazolidinone, MDR-PA BL-BLI, MDR-PA BL-BLI standard of care (SOC), MDR-PA carbapenem +/- BLI standard of care (SOC), VRE lipopeptide, ESCRE/CRE cefepime/cefidericol, MDR-PA carbapenem +/- BLI, ESCRE/CRE Fluoroquinolone, ESCRE/CRE carbapenem +/- BLI standard of care (SOC), MDR-PA cefepime/cefidericol, ESCRE/CRE BL-BLI, VRE oxazolidinone, VRE oxazolidinone standard of care (SOC), VRE lipopeptide standard of care (SOC), MDR-PA Fluoroquinolone standard of care (SOC), ESCRE/CRE cefepime/cefidericol standard of care (SOC)
Enterobacterial Infection Clinical Trial 2023: PMT Highlights & Side Effects. Trial Name: NCT05632315 — Phase 2
PMT (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632315 — Phase 2
~100 spots leftby Jan 2026
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