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Microbiome Therapy
Phage Therapy for MDRO Decolonization
Phase 2
Waitlist Available
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-, 30-, 90- and 180 day follow up visits
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-, 30-, 90- and 180 day follow up visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-, 30-, 90- and 180 day follow up visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of adverse events of special interest (AESIs)
Frequency of medically attended adverse events (MAAEs)
Frequency of serious adverse events (SAEs)
+2 moreSecondary outcome measures
All-cause mortality
Bacteria growth in blood samples
Colectomy occurrence
+9 moreTrial 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 resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol
Group VI: MDR-PA carbapenem +/- BLIExperimental Treatment1 Intervention
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI
Group VII: MDR-PA FluoroquinoloneExperimental Treatment1 Intervention
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone
Group VIII: MDR-PA BL-BLIExperimental Treatment1 Intervention
MDRO: two-class resistant 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 resistant 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 resistant 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 resistant 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 resistant 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
2,000 Previous Clinical Trials
42,879,938 Total Patients Enrolled
20 Trials studying Infections
11,862 Patients Enrolled for Infections
Brendan J KellyPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can only receive nutrition and medications through my veins.I am of childbearing age and will take a pregnancy test before receiving the treatment.I do not have any major gut diseases that could interfere with a fecal transplant.My treatment goal is comfort, not cure.I am using effective birth control during and after the study.I am on antibiotics that match my infection's resistance profile.I am expected to be treated with antibiotics in the hospital for my infection for at least 5 days.I am 18 years old or older.I have an infection caused by bacteria resistant to multiple antibiotics.I am within 2 to 7 days of finishing my antibiotics for a specific infection.
Research Study Groups:
This trial has the following groups:- Group 1: ESCRE/CRE Fluoroquinolone standard of care (SOC)
- Group 2: MRSA lipo/glycopeptide standard of care (SOC)
- Group 3: MRSA oxazolidinone standard of care (SOC)
- Group 4: ESCRE/CRE BL-BLI standard of care (SOC)
- Group 5: ESCRE/CRE carbapenem +/- BLI
- Group 6: MDR-PA cefepime/cefidericol standard of care (SOC)
- Group 7: MDR-PA Fluoroquinolone
- Group 8: MRSA lipo/glycopeptide
- Group 9: MRSA oxazolidinone
- Group 10: MDR-PA BL-BLI
- Group 11: MDR-PA BL-BLI standard of care (SOC)
- Group 12: MDR-PA carbapenem +/- BLI standard of care (SOC)
- Group 13: VRE lipopeptide
- Group 14: ESCRE/CRE cefepime/cefidericol
- Group 15: MDR-PA carbapenem +/- BLI
- Group 16: ESCRE/CRE Fluoroquinolone
- Group 17: ESCRE/CRE carbapenem +/- BLI standard of care (SOC)
- Group 18: MDR-PA cefepime/cefidericol
- Group 19: ESCRE/CRE BL-BLI
- Group 20: VRE oxazolidinone
- Group 21: VRE oxazolidinone standard of care (SOC)
- Group 22: VRE lipopeptide standard of care (SOC)
- Group 23: MDR-PA Fluoroquinolone standard of care (SOC)
- Group 24: ESCRE/CRE cefepime/cefidericol standard of care (SOC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any potential risks associated with using ESCRE/CRE Fluoroquinolone?
"Although there is some evidence for its safety, ESCRE/CRE Fluoroquinolone has yet to show efficacy in clinical trials and thus received a score of 2."
Answered by AI
Is there still room to enroll individuals in this research?
"The information on clinicaltrials.gov reveals that this study is not actively recruiting at the moment. Originally posted in January 1st 2023, and last updated November 17th 2022, it has yet to search for participants; however there are still 800 other studies on the website currently seeking patients."
Answered by AI
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