Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Fidaxomicin
Intervention description: 200mg twice daily for 10 days followed by 200mg once daily for 20 days to prevent future recurrence of CDI
Intervention MeSH terms: Fidaxomicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent; infection

Summary:

      This is a medical research study designed to look at the safety and efficacy of 30-day course
      of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an
      infection that results when the normal flora (resident bacteria) of the colon is
      substantially altered by antibiotic treatment. The decrease in this normal flora allows for
      the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by
      Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode
      of recurrent CDI have been studied using a 10-day course of fidaxomicin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older.

          2. Able to provide informed consent.

          3. Willing and able to comply with all the required study procedures.

          4. A positive stool test for C. difficile toxin/gene using either PCR or enzyme
             immunoassay within 3 months of recruitment.

          5. History of at least ≥ 2 recurrent CDI within 6 months where recurrence is deﬁned as
             return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution
             for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy
             and positive stool test for C. difficile toxin or toxin gene and/or ongoing symptoms
             consistent with CDI despite at least 5 days of treatment using oral vancomycin.

          6. Has more than three unformed bowel movements or 200 mL of stool for individuals with a
             stool collection device such as rectal tube or colostomy during a 24-hour period at
             the time of initiation of fidaxomicin. Participants will be enrolled when they meet
             inclusion criteria 1 - 5; will be initiated at fidaxomicin when they have CDI symptoms
             and stool will be tested for C. difficile toxin/gene. Only those with positive stool
             for C. difficile toxin/gene with current episode of CDI will continue with the study

          7. Females of child bearing potential must be willing to use acceptable birth control as
             per the Health Canada Guidance Document: Considerations for Inclusion of Women in
             Clinical Trials and Analysis of Sex Differences.

        Exclusion Criteria:

          1. Planned or actively taking an investigational product for another study.

          2. Prior fidaxomicin use.

          3. Hypersensitivity to fidaxomicin or to any ingredient in the formulation or component
             of the container.

          4. Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray or life
             expectancy of less than 72 hours.

          5. Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli,
             Yersinia or Campylobacter.

          6. Anticipated requirement for systemic antibiotic therapy for more than 7 days during
             the study period.

          7. Actively taking Saccharomyces boulardii or other probiotics other than yogurt.

          8. Any condition that, in the opinion of the investigator, that the treatment may pose a
             health risk to the subject.

          9. Pregnant or lactating.