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NCT05632315 · ClinicalTrials.gov registry record · Phase 2
PMT for MDRO Decolonization
A Phase 2 study of Methicillin-resistant Staphylococcus Aureus and Pseudomonas Aeruginosa, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 3
- Study locations
NCT05632315: Recruiting Phase 2 study of Methicillin-resistant Staphylococcus Aureus and Pseudomonas Aeruginosa, sponsored by University of Pennsylvania.
NCT05632315 is a Phase 2 study of Methicillin-resistant Staphylococcus Aureus and Pseudomonas Aeruginosa that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 150 participants, below the 15,875-participant average among 5 other Methicillin-resistant Staphylococcus Aureus trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05632315, a Phase 2 study of Methicillin-resistant Staphylococcus Aureus and Pseudomonas Aeruginosa, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
measured by selective stool culture, resolution will be defined as the absence of growth of the index MDRO on selective culture media.
Conditions Studied
Interventions
- DRUG PMT
Study Locations (3)
Georgia
- Emory University - Grady Memorial Hospital - Atlanta
Missouri
- Washington University - St Louis
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT05632315 shows while recruiting
NCT05632315 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 15,875-participant average among 5 other Methicillin-resistant Staphylococcus Aureus trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Methicillin-resistant Staphylococcus Aureus appearing as the primary indexed condition, and to 1 intervention - of which PMT is the first listed.
NCT05632315 reports a single indexed study location in Georgia, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05632315 about?
NCT05632315 is a clinical study titled "PMT for MDRO Decolonization". 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.
What is the current status of trial NCT05632315?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-08-19. Estimated completion is 2026-05.
What conditions does trial NCT05632315 study?
This clinical trial studies the following conditions: Methicillin-resistant Staphylococcus Aureus, Pseudomonas Aeruginosa, Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections, VRE Infection.
What interventions are being tested in trial NCT05632315?
The interventions under investigation include: PMT (DRUG).
Who is sponsoring clinical trial NCT05632315?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05632315 being conducted?
This trial has 3 study locations across Georgia, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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