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
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to provide signed and dated informed consent * Males and females between 18 - 75 years old inclusive * Documented history of first recurrent Clostridioides difficile (former Clostridium difficile) infection (rCDI), confirmed by a positive C. difficile test (Toxin A+B positive or Toxin B only), with initial infection occurring within the previous 12-months. * Must, in accordance with standard of care practices, have completed a SOC oral antibiotic therapy for the first rCDI no more than 5 days prior to the date of enrolment (baseline visit- Day 0). * Must not have an…
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.
Location
- Emory University HospitalAtlanta, Georgia