Optimal Treatment for Recurrent Clostridium Difficile

Stopped early · Phase 4

Conditions studied: Clostridium, Difficile, Fidaxomicin, Vancomycin

In brief

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.

Key facts

Study ID

NCT02667418

Run by

VA Office of Research and Development

People needed

308

Starts

2016-02-19

Expected to finish

2024-08-31

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States
• Southern Arizona VA Health Care System, Tucson, AZ — Tucson, Arizona, United States
• Central Arkansas Veterans Healthcare System, Little Rock, AR — Little Rock, Arkansas, United States
• VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• VA Northern California Health Care System, Mather, CA — Sacramento, California, United States
• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
• Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Rehabilitation R&D Service, Baltimore, MD — Baltimore, Maryland, United States
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
• John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States
• Asheville VA Medical Center, Asheville, NC — Asheville, North Carolina, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Oklahoma City VA Medical Center, Oklahoma City, OK — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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