Observational Study of Stool Toxin Levels After Standard Antibiotic Treatment for Recurrent Clostridioides difficile Infection in Adults

What this Trial Is About

Researchers are evaluating the risk of recurrence of Clostridioides difficile infection rCDI after standard antibiotic treatment for a first recurrence. This observational study aims to determine the rate of CDI recurrence within 8 weeks after antibiotic therapy and to explore whether toxin levels of Toxin A and B in stool at baseline can predict the risk of recurrence. The study enrolls otherwise healthy adults with a documented history of first recurrent CDI and confirmed positive toxin B test within the past year. Participants will have completed standard oral antibiotic treatment for their first rCDI no more than five days before enrollment. They will be followed for approximately 9 weeks, including an 8-week follow-up period after antibiotic treatment. Stool samples will be collected at baseline, week 2, and week 8 to measure levels of Toxin A and B using sensitive assays. The study will observe participants undergoing standard-of-care antibiotic treatment without altering their therapy. During the study, participants will attend four visits over about 9 weeks, which can be conducted in person or remotely via phone. At these visits, stool samples and clinical assessments will be collected to monitor for CDI recurrence and toxin levels. Researchers will measure the proportion of subjects experiencing CDI recurrence within 8 weeks, and also analyze the correlation between post-treatment toxin levels and recurrence. The study duration for each participant is approximately 9 weeks following antibiotic treatment completion.

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