Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
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.
Clostridium difficile (C. difficile) infection (CDI) is one of the most frequent causes of
 healthcare associated infections and its rates are also growing in the community. The
 efficacy of standard antibiotics especially for recurrent CDI is limited as oral vancomycin
 and metronidazole also suppress the growth of anaerobic bacteria such as Bacteroides fragilis
 group which protect against proliferation of C. difficile. In contrast, in vitro study has
 shown that fidaxomicin has negligible activity against B. fragilis. The persistent disruption
 of healthy colonic flora may be the reason for recurrences following a course of treatment
 with metronidazole or vancomycin. Fidaxomicin has shown to reduce recurrences by
 approximately 50% when compared to oral vancomycin for primary or 1st episode of recurrent
 CDI.

 Determining the efficacy and safety of 30-day duration of fidaxomicin for recurrent CDI
 through an open label clinical trial has important implications for policy making related to
 the drug reimbursement programs. In addition, the results of this study will be instrumental
 in demonstrating to the scientific and healthcare communities there may be a role for the
 30-day course of fidaxomicin as a treatment modality for recurrent CDI. Curing CDI will
 restore the health and quality of life not just at the individual patient level but to the
 healthcare communities as well. Patients with refractory CDI require prolonged hospital
 admission, which increases the organism burden within the healthcare facilities. This in turn
 leads to the spread of the infection to other vulnerable patients. If a 30-day course of
 fidaxomicin proves to be safe and effective in curing patients with recurrent CDI, it will
 reduce the risk of severe complications in each patient and reduce transmission of CDI to
 other susceptible patients.
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, E. coli 0157H7, 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.