Further MT for Antibiotic-Resistant Bacterial Colonization

NCT05835206 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: STUDY000036131U54CK000601-012025P009597
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection. Limited data from prior studies suggest that MT may be an effective treatment to reduce intestinal MDRO colonization Although shedding of MDROs from patients to their surrounding environment is a recognized pathway of transmission, the potential effect of MT on the transmission of MDRO to other patients in the hospital environment is unclear. This study will test the safety and efficacy of MT for this use in hospitalized patients. This study will also help design larger studies. The MT may help reduce MDROs that colonize the gut. By reducing colonization before infections happen, this could help doctors avoid using "last resort" antibiotics that can have serious side effects like kidney damage. The reduction in MDROs after MT was originally identified in patients treated with MT for recurrent Clostridioides difficile (often called "C. diff") diarrhea. It has been shown that a type of MT called fecal microbiota transplant (FMT) can eliminate both C. difficile and other resistant bacteria.

Conditions

Intestinal Multi-drug Resistant Organism Colonization

Keywords

Carbapenem-resistant Enterobacteriaceae (CRE); Vancomycin-Resistant Enterococcus (VRE); Extended Spectrum Beta-Lactamase (ESBL); Multi-Drug Resistant (MDR) Acinetobacter; Multi-Drug Resistant (MDR) Pseudomonas

Outcome Measures

Primary Outcomes (2)

• Change in stool MDRO colony-forming unit (CFU) density

  MDRO colony-forming unit (CFU) densities from quantitative stool cultures in placebo vs IP-treated participants.

  Day 0, day 14 of last cycle (each cycle is 14 days), and 28 weeks

• Change in proportion of MDRO colonized participants after last treatment cycle with the investigational product (IP)

  Proportion of stool cultures positive for any target MDRO will be compared in IP-treated vs placebo-treated participants.

  Day 0, day 14 of last cycle (each cycle is 14 days), and 28 weeks

Secondary Outcomes (4)

• Estimate safety of the IP for MDRO colonization after infection

  Day 0, day 7, day 14 of last cycle (each cycle is 14 days), and 28 weeks

• Severity of adverse events caused by administration of the investigational product

  Day 0, day 7, day 14 of last cycle (each cycle is 14 days), and 28 weeks

• Estimate efficacy of the IP for reducing recurrent MDRO infection

  Day 0, 24 weeks post Day 14 of last cycle (each cycle is 14 days)

• Time to recurrent MDRO infection after IP administration

  Day 0, 24 weeks post Day 14 of last cycle (each cycle is 14 days)

Study Arms (2)

microbiome therapeutic

EXPERIMENTAL

The study intervention is manufactured from a healthy screened donor as an investigational product (IP) and delivered via swallowed capsule after room reset of the patient's hospital room.

Drug: Microbiome Therapeutic

Placebo

PLACEBO COMPARATOR

The control arm will remain in routine contact precautions per standard of care, take placebo capsules, and have a room reset.

Drug: Placebo

Interventions

Microbiome Therapeutic DRUG

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.

Also known as: Intervention Group

microbiome therapeutic

Placebo DRUG

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.

Also known as: Control Group

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to (or have an available Legally Authorized Representative who is able to) understand and be willing to sign a written informed consent document.
• Be at least 18 years old at the time of consent.
• Be able and willing to comply with all study protocol requirements, including the ability to swallow capsules.
• Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Acinetobacter, and/or MDR Pseudomonas) as detected by bacterial culture of stool or perianal/rectal swab.
• Be able and willing to discontinue systemic antibiotics at least one day prior to study Day 0 and for as long as medically able to do so throughout the study.
• Be willing to discontinue probiotics or other microbiota restoration therapies at least one day prior to study Day 0 and for the duration of study participation.
• The effects of the IP on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

You may not qualify if:

• Be pregnant, breastfeeding, lactating, or planning a pregnancy during the study duration (through 4 weeks after the last dose of investigational product, or IP), if women of childbearing potential (WOCBP).
• Have any other intercurrent acute illness that in the opinion of the investigator will preclude the subject from entering the study.
• Be on systemic antibiotics for any reason other than if the MDRO infection was recent or the potential participant is still taking antibiotics for target MDRO at the time of screening. If the latter, the participant must be able (in the opinion of their treating providers) to complete the planned antibiotic course by study Day -1.
• Have a compromised immune system, defined as AIDS with a cluster of differentiation 4 (CD4)+ T-cell count \<200, history of documented absolute neutrophil count (ANC) \<1,000 neutrophils/mL within 14 days of D0, active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months of enrollment or history of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year.
• Have a history of significant food allergy that led to anaphylaxis or hospitalization.
• Have a life expectancy of 24 weeks or less
• Have any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to known active intravenous drug or alcohol abuse, psychiatric illness, and/or social situation
• Participated in an investigational study that also meets one of the following criteria: Received an interventional agent (drug, device, or procedure) in the last 28 days or enrollment in any other interventional study for MDROs.

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (6)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University Clinical Research Network

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University Hospital (EUH)

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University at Wesley Woods Hospital

Atlanta, Georgia, 30329, United States

RECRUITING

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

RECRUITING

MeSH Terms

Conditions

Pseudomonas Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michael Woodworth, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Woodworth, MD, MSc

CONTACT

404-778-1691; mwoodwo@emory.edu

Ella Wetzel, MS

CONTACT

770-946-2109; evwetze@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: April 25, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of publication
• Access Criteria: Data will be uploaded to relevant repositories (e.g. National Center for Biotechnology Information (NCBI), Sequence Read Archive (SRA) for sequencing data and Dataverse or similar for clinical trial data)

Locations

US (6)