PMT for MDRO Decolonization

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

A Phase II Randomized Trial to Evaluate the Impact of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products on Recipient and Environmental Colonization With Multidrug-Resistant Organisms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05632315
• Other study ID #: 852552
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Brendan J Kelly, MD, MS
• Phone: (215) 662-6932
• Email: brendank[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 resistant 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 planned completion of antibiotic treatment for 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 (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Enterobacteriaceae Infections
• Infections
• Methicillin-resistant Staphylococcus Aureus
• Pseudomonas Aeruginosa
• VRE Infection

Intervention

Drug:
• PMT
Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002)

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with resolution of index MDRO colonization of the gut	measured by selective stool culture, resolution will be defined as the absence of growth of the index MDRO on selective culture media.	30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Primary	Frequency of solicited adverse events (AEs)		randomization until 180 day visit after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Primary	Frequency of serious adverse events (SAEs)		randomization until 180 day visit after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Primary	Frequency of adverse events of special interest (AESIs)		randomization until 180 day visit after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Primary	Frequency of medically attended adverse events (MAAEs)		randomization until 180 day visit after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Eradication of gut colonization with the index MDRO	i.e., negative selective bacterial culture for the index MDRO to be assessed in addition to primary endpoint	7 days and 90 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Eradication of gut colonization with any of the included MDROs		7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	All-cause mortality		30- and 60-days following SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Colectomy occurrence		within 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Cumulative days of hospitalization		from randomization to 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Cumulative days of intensive care		from randomization to 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Bacteria growth in blood samples		from randomization to 30 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Hospital admission		within 60 days of discharge from index hospitalization
Secondary	Hospital admission		within 180 days after SCAIM (scheduled completion of appropriate antibiotics for the index MDRO infection)
Secondary	Instances of worsened abdominal pain, fever, tachycardia, and hypotension		randomization until 180-day visit
Secondary	Instances of aspiration (including reduced oxygen saturation, tachypnea, or respiratory distress (PMT-002 upper entral delivery only)		randomization until 180-day visit
Secondary	Instances of fever, diarrhea, nausea and vomiting		7-, 30-, 90- and 180 day follow up visits
Secondary	Instances of new metabolic disease, including hyperglycemia, thyroid disease, weight gain or loss		30-, 90- and 180 day follow up visits