Optimal Treatment for Recurrent Clostridium Difficile

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Fidaxomicin; Vancomycin

Criteria

Inclusion Criteria:

• Informed consent obtained and signed

• Age > 18

• If female, participant must not be pregnant or nursing

• Negative pregnancy test required for females <61 years of age or without prior hysterectomy

• Confirmed current diagnosis of CDI, determined by having

• >3 loose or semi-formed stools for participants over 24 hours AND

• Positive stool assay for C. difficile

• EIA positive for toxin A/B; or

• Cytotoxin assay; or

• Nucleic Acid Amplification Test (NAAT, PCR or LAMP) based detection of toxigenic C. difficile

• Current episode represents the first recurrent episode of CDI within 3 months of the primary CDI episode in a patient who has not had CDI in the 3 months prior to the primary episode OR a second recurrent CDI episode occurring within 3 months of the first recurrent episode, as defined above

• At least one of the previous CDI episodes must have been confirmed by a stool assay for C. difficile

Exclusion Criteria:

• Inability to provide informed consent

• Inability to take oral capsules

• Receipt of >72 hours of antibiotics considered effective in the treatment of CDI, including:

• metronidazole

• vancomycin

• fidaxomicin

• nitazoxanide

• rifaximin

• Prior infusion of bezlotoxumab within the previous 6 months

• Known presence of fulminant CDI, including hypotension, severe ileus or GI obstruction or incipient toxic megacolon

• Receipt of more than a single course of oral vancomycin, fidaxomicin, or a vancomycin tapering regimen since the primary episode of CDI as defined above

• Known allergy to vancomycin or fidaxomicin

• Acute or chronic diarrhea due to inflammatory bowel disease or other cause (e.g., presence of an ileostomy or colostomy) that would confound evaluation of response to CDI treatment

• Anticipation of need for long term systemic antibiotic treatment (beyond 7 days)

• Patients with an active diagnosis of COVID-19 will be excluded from the study, but patients who have recovered (per current CDC guidance on discontinuation of transmission-based precautions) can be included in the study.