Antibiotics for C. Difficile (OpTION Trial)

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.

Eligibility Criteria

Adults over 18 with a confirmed first or second recurrence of C. difficile infection within the past 3 months, who have had more than three loose stools in 24 hours and can provide informed consent. Pregnant or nursing women are excluded, as well as those allergic to vancomycin or fidaxomicin, on long-term antibiotics, with severe CDI symptoms like hypotension or ileus, other causes of chronic diarrhea, prior extensive treatment for CDI, active COVID-19 (unless recovered), and inability to take oral medication.

Inclusion Criteria

I have been diagnosed with CDI, with symptoms and positive stool test results.

I have had more than 3 loose stools in the last 24 hours.

I am older than 18 years.

I am not pregnant or breastfeeding.

Exclusion Criteria

I have ongoing diarrhea not related to CDI that could affect treatment evaluation.

I have taken antibiotics for over 72 hours to treat CDI.

I have severe intestinal issues including very low blood pressure, blockage, or a rapidly swelling colon.

I have taken more than one course of specific antibiotics for a C. diff infection.

Participant Groups

This study is testing if treating recurrent C. difficile infections with either fidaxomicin alone or vancomycin followed by a tapering dose of vancomycin is more effective than just standard vancomycin treatment. Participants will be randomly assigned to one of these treatments to compare outcomes.

3Treatment groups

Experimental Treatment

Group I: Vancomycin T/PExperimental Treatment1 Intervention

Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile

Group II: VancomycinExperimental Treatment1 Intervention

Standard 10-day vancomycin treatment for Clostridium difficile

Group III: FidaxomicinExperimental Treatment1 Intervention

Standard 10-day fidaxomicin treatment for Clostridium difficile