PMT for MDRO Decolonization

Inclusion Criteria:

1. Multidrug-resistant organism (MDRO) infection of the bloodstream, respiratory tract,or urinary tract. Qualifying MDROs include extended-spectrum cephalosporin-resistantEnterobacterales (ESCRE) or carbapenem-resistant Enterobacterales (CRE), Pseudomonasaeruginosa non-susceptible to two or more classes of antibiotics (MDR-PA),vancomycin-resistant Enterococcus (VRE), and methicillin-resistant Staphylococcusaureus (MRSA).

2. On appropriate antibiotic treatment per clinical phenotypic susceptibility testingof the qualifying MDRO, and with a qualifying antibiotic class. Qualifyingantibiotic classes include beta-lactam + beta-lactamase inhibitor, carbapenem (withor without betalactamase inhibitor), fluoroquinolone, lipopeptide, glycopeptide, oroxazolidinone.

3. Expected duration of inpatient antibiotic treatment for index MDRO infection atleast 5 days total.

4. At least two calendar days remaining, and no more than 7 calendar days remainingprior to SCAIM (scheduled completion of inpatient appropriate antibiotics for theindex 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

8. For subjects of childbearing potential (ages 18 to 55) and who are randomizedto receive the intervention, the subject must have a negative pregnancy testwithin 24 hours prior to product administration

9. Female or male subjects (ages 18 to 55) of reproductive potential engaged inactive sexual activity that could lead to a pregnancy must agree to use one ofthe following forms of birth control while receiving study medications andthrough 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

10. Known gastrointestinal disease that could affect the safety of fecal microbiotatransplant at time of enrollment:

11. Inflammatory Bowel Disease (IBD)

12. Short Gut Syndrome

13. Fistulas

14. Bowel resection surgery

15. Colitis