PMT for MDRO Decolonization

Launched by UNIVERSITY OF PENNSYLVANIA · Nov 17, 2022

Keywords

ClinConnect Summary

The clinical trial titled "PMT for MDRO Decolonization" is investigating whether a treatment called fecal microbiota transplant, using a product known as Penn Microbiome Therapy (PMT), can help eliminate antibiotic-resistant bacteria in patients who are already receiving standard antibiotic therapy. This study is particularly focused on patients with serious infections caused by multidrug-resistant organisms (MDROs), such as certain strains of bacteria that have become resistant to common antibiotics. The trial is currently recruiting participants aged 18 and older who have a qualifying MDRO infection and are expected to receive at least five days of antibiotic treatment.

Eligible participants will be closely monitored throughout the trial. They will receive either the PMT treatment or continue with their standard care, and the goal is to see if the addition of this new therapy improves their chances of recovering from the infection. It’s important to note that there are specific health conditions that would prevent someone from joining the trial, such as severe allergies or certain gastrointestinal diseases. This study aims to provide valuable information on how to better treat infections caused by these challenging bacteria, helping to pave the way for more effective therapies in the future.

Gender

ALL

Eligibility criteria

• 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 non-susceptible 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 SCAIM (scheduled completion of inpatient appropriate antibiotics for the 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 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