Further MT for Antibiotic-Resistant Bacterial Colonization in Inpatients

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 25, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

July 30, 2026

Conditions
Multi-drug Resistant Organism
Interventions
DRUG

Microbiome Therapeutic

"Participants will receive a single course of study treatment (IP, Encapsulated Microbiota): Orally delivered, non-frozen, encapsulated investigational intestinal microbiota, consisting of 16 capsules. One dose (8 capsules) is administered daily (QD) for 2 days. The capsules are to be taken orally with water on an empty stomach. Each dose will be taken approximately every 24 hours, with a minimum of 12 hours from the previous dose to a maximum of 36 hours. Both doses must be completed within the stated 36 hours ±12 hours. Depending on the time of the first dose, dosing may occur over 3 calendar days.~A second cycle will begin and a second treatment will be given if the participant is still MDRO positive on Day 14 of Cycle 1. If applicable, Cycle 2 will begin within 7 days of Day 14."

DRUG

Placebo

"Participants will receive a single course of study treatment (Color-matched placebo capsules containing microcrystalline cellulose (MCC) powder), consisting of 16 capsules. One dose (8 capsules) is administered daily (QD) for 2 days. The capsules are to be taken orally with water on an empty stomach. Each dose will be taken approximately every 24 hours, with a minimum of 12 hours from the previous dose to a maximum of 36 hours. Both doses must be completed within the stated 36 hours ±12 hours. Depending on the time of the first dose, dosing may occur over 3 calendar days.~A second cycle will begin and a second treatment will be given if the participant is still MDRO positive on Day 14 of Cycle 1. If applicable, Cycle 2 will begin within 7 days of Day 14."

Trial Locations (5)

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30322

RECRUITING

Emory Rehabilitation Hospital, Atlanta

RECRUITING

Emory University Clinical Research Network, Atlanta

RECRUITING

Emory University Hospital (EUH), Atlanta

30329

RECRUITING

Emory University at Wesley Woods Hospital, Atlanta

All Listed Sponsors
collaborator

Centers for Disease Control and Prevention

FED

lead

Emory University

OTHER