RECRUITING

Further MT for AntIbiotic-Resistant Bacterial Colonization in Inpatients

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Conditions

Multi-drug Resistant OrganismCarbapenem-resistant Enterobacteriaceae (CRE)Vancomycin-Resistant Enterococcus (VRE)Extended Spectrum Beta-Lactamase (ESBL)Multi-Drug Resistant (MDR) AcinetobacterMulti-Drug Resistant (MDR) Pseudomonas

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial to Further Microbiota Therapy for AntIbiotic-Resistant Bacterial Colonization in Inpatients.

Quick Facts

Study Start:2024-04-25
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05835206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Be at least 18 years old at the time of consent.
  3. * Be able and willing to comply with all study protocol requirements, including the ability to swallow capsules.
  4. * 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.
  5. * 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.
  6. * 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.
  7. * 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.
  1. * 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).
  2. * Have known uncontrolled intercurrent illness(es) such as, but not limited to Symptomatic congestive heart failure, acute coronary syndrome, cardiac arrhythmia, untreated in situ colorectal cancer, toxic megacolon or ileus, use of medications that decrease GI motility and increase broncho-aspiration risk (e.g. loperamide, diphenoxylate/atropine, cholestyramine), or history of positive stool studies or cultures in the last 30 days for ova, parasites, Salmonella, Shigella, Campylobacter, or other enteropathogens other than those detected by screening MDRO stool cultures for inclusion.
  3. * Have any other intercurrent acute illness that in the opinion of the investigator will preclude the subject from entering the study.
  4. * 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.
  5. * 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.
  6. * Have a history of significant food allergy that led to anaphylaxis or hospitalization.
  7. * Have a life expectancy of 24 weeks or less
  8. * 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
  9. * 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.

Contacts and Locations

Study Contact

Michael Woodworth, MD, MSc
CONTACT
404-778-1691
mwoodwo@emory.edu
Amanda Strudwick, RN
CONTACT
404-727-9193
astrudw@emory.edu

Principal Investigator

Michael Woodworth, MD, MSc
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
United States
Emory University Clinical Research Network
Atlanta, Georgia, 30322
United States
Emory University Hospital (EUH)
Atlanta, Georgia, 30322
United States
Emory University at Wesley Woods Hospital
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Michael Woodworth, MD, MSc, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-25
Study Completion Date2025-06

Study Record Updates

Study Start Date2024-04-25
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Multi-drug Resistant Organism