C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Bactolife A/S
Study ID
NCT07250724
Status
Recruiting
Apply to this trial

Conditions

  • Clostridioides Difficile Infection Recurrence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Participants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment. — OTHER
    Participants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment.

Study Details

Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations". The goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection. The main questions it aims to answer are: * What is the recurrence rate of CDI in the 8 weeks following antibiotic treatment for a first recurrence of CDI? * Does toxin levels of Toxin A and/or B from C. Diff. at baseline predict CDI recurrence risk? Participants will: * Undergo standard of care Antibiotic treatment for first recurrence of CDI * Visit their clinic at 4 different visits over a time period of approximately 9 weeks. (Visits can also be performed remote/via phone call.)

Key Dates

First listed
Nov 26, 2025
Start date
Mar 1, 2026
Status verified
Jun 2026
Primary completion
Oct 15, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
60 participants (estimated)

Primary Outcome Measure

The proportion of subjects experiencing CDI recurrence in the time period between baseline and end of study follow-up. [ Time Frame: Within the 8 week time period between baseline and end of follow-up ]

Central Contacts

  • Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials
    +1 312 818 8905
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Jennifer C Truell, MA, MPH
[email protected]
404-778-0014
Colleen S Kraft, MD
[email protected]
404-712-8889
Colleen S Kraft, MD, MSc (PRINCIPAL_INVESTIGATOR)
Nirja Mehta, MD (SUB_INVESTIGATOR)
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073
Christine Batchelder
[email protected]
248-551-0099
Matthew Sims, Dr.
[email protected]
248-551-0027
Matthew Sims, Dr. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic, MinnesotaRochesterMinnesota55905
Patricia Kammer
[email protected]
507-538-1827
Christian Coy
[email protected]
507-538-1827
Darrell s Pardi, Dr. (PRINCIPAL_INVESTIGATOR)
Sahil Khanna, Dr. (SUB_INVESTIGATOR)
University of Wisconsin-MadisonMadisonWisconsin53705-2281
Shelly Zimbric
[email protected]
160-826-58799
Nasia Safdar
[email protected]
160-826-58799
Nasia Safdar, MD, PhD, Prof. (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital· Atlanta, GACorewell Health William Beaumont University Hospital· Royal Oak, MIMayo Clinic, Minnesota· Rochester, MNUniversity of Wisconsin-Madison· Madison, WI

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