A Prospective, Observational Study to Evaluate C. Difficile Toxin Levels in Stool in Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Bactolife A/S
Summary
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.)
Description
Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations". This prospective observational study will enrol 60 otherwise healthy adults with a documented history of first recurrent Clostridioides difficile infection (rCDI). Eligible participants must have had a confirmed positive toxin B test for C. difficile, with the initial infection occurring within the past 12 months. At the time of enrolment (Day 0), participants must have completed a standard-of-care oral antibiotic therapy for their first rCDI no more…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Participants will be included in the study if they meet all of the following criteria At the time of screening: * Able to provide signed and dated informed consent * Males and females from the age of 18 and above * Planned or already ongoing SoC antibiotic treatment for diagnosed Clostridiodides difficile infection (CDI). All types of diagnosis/testing algorithms, and antibiotic taper regimes acceptable. * Documented history of, minimum one previous CDI episode occurring within the last 12 months. At the Time of Baseline Visit: \- Have completed the antibiotic treatment regime for the curr…
Interventions
- OtherParticipants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment.
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.
Locations (4)
- Emory University HospitalAtlanta, Georgia
- Corewell Health William Beaumont University HospitalRoyal Oak, Michigan
- Mayo Clinic, MinnesotaRochester, Minnesota
- University of Wisconsin-MadisonMadison, Wisconsin