PMT for MDRO Decolonization

Inclusion criteria

• 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).
• 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.
• Expected duration of inpatient antibiotic treatment for index MDRO infection at least 5 days total.
• 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).
• Age ≥ 18 years.

Exclusion criteria

• Evidence of colon/small bowel perforation at the time of study screening.
• Unable to tolerate enteral and enema nutrition and medication administration (i.e., only able to tolerate intravenous nutrition and medications).
• Goals of care are directed to comfort rather than curative measures.
• Moderate or severe neutropenia within 10 calendar days prior to enrollment.
• Known food allergy that could lead to anaphylaxis.
• Known allergy to fecal microbiota transplant products or their components
• Pregnancy or lactation

• 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
• 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

• Known gastrointestinal disease that could affect the safety of fecal microbiota transplant at time of enrollment:

• Inflammatory Bowel Disease (IBD)
• Short Gut Syndrome
• Fistulas
• Bowel resection surgery
• Colitis