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New hope for recurring c. diff: which treatment works best?

NCT ID NCT02667418

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tested three different antibiotic regimens for people with recurrent Clostridium difficile infection (C. diff), a serious gut infection that keeps coming back. The goal was to see if newer drugs like fidaxomicin or a tapered/pulsed course of vancomycin work better than standard vancomycin treatment. The trial was stopped early, but it aimed to find the best way to keep symptoms from returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fidaxomicin and vancomycin
What this could lead to
If successful, this could identify a more effective treatment regimen for recurrent C. diff infection, reducing relapse rates.
What could go wrong
The trial was terminated early, so results may be incomplete. It's a phase 4 study, but limited data may reduce confidence in findings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

308 people

The number who actually took part.

Started

Feb 2016

Finished

Aug 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridium Difficile Fidaxomicin Vancomycin

Contacts and locations

Locations

  • Asheville VA Medical Center, Asheville, NC

    Asheville, North Carolina, 28805-2576, United States

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33744-0000, United States

  • Central Arkansas Veterans Healthcare System, Little Rock, AR

    Little Rock, Arkansas, 72205, United States

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin, 53295-0001, United States

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141, United States

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612, United States

  • John D. Dingell VA Medical Center, Detroit, MI

    Detroit, Michigan, 48201-1916, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma, 73104-5007, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012, United States

  • Rehabilitation R&D Service, Baltimore, MD

    Baltimore, Maryland, 21202, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211, United States

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229, United States

  • Southern Arizona VA Health Care System, Tucson, AZ

    Tucson, Arizona, 85723-0001, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817, United States

  • VA Caribbean Healthcare System, San Juan, PR

    San Juan, 00921, Puerto Rico

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167, United States

  • VA Northern California Health Care System, Mather, CA

    Sacramento, California, 95655-4200, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290, United States

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148, United States

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161, United States

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