- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02395848
Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
Prospective, Open-label Trial to Evaluate Efficacy of 30-day Duration of Fidaxomicin in Patients With Recurrent C. Difficile Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
BC - British Columbia
-
Victoria, BC - British Columbia, Canada, V8R 6CT
- Christine Lee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or older.
- Able to provide informed consent.
- Willing and able to comply with all the required study procedures.
- A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment.
- 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.
- 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
- 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:
- Planned or actively taking an investigational product for another study.
- Prior fidaxomicin use.
- Hypersensitivity to fidaxomicin or to any ingredient in the formulation or component of the container.
- Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray or life expectancy of less than 72 hours.
- Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
- Anticipated requirement for systemic antibiotic therapy for more than 7 days during the study period.
- Actively taking Saccharomyces boulardii or other probiotics other than yogurt.
- Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
- Pregnant or lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fidaxomicin
30-day Fidaxomicin ( 200mg twice daily x 10 days and 200mg once daily x 20 days.
|
200mg twice daily for 10 days followed by 200mg once daily for 20 days to prevent future recurrence of CDI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response at 30-day Completion of Fidaxomicin
Time Frame: 30 days
|
clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well through study day 30.
|
30 days
|
Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin
Time Frame: 8 week following completion of fidaxomicin
|
sustained clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well 8 weeks following completion of fidaxomicin
|
8 week following completion of fidaxomicin
|
Treatment Failure
Time Frame: Up to 8 weeks following completion of fidaxomicin
|
patients not meeting the definition of cure and requiring additional antibiotics for current CDI episode
|
Up to 8 weeks following completion of fidaxomicin
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evaluation of safety of 30-day duration of fidaxomicin based on questionnaire
Time Frame: up to 8 weeks following the last dose of fidaxomicin
|
Number of patients who experience significant adverse events not described in the consent form
|
up to 8 weeks following the last dose of fidaxomicin
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine H Lee, MD, Vancouver Island Health Authority
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDI.FIDAXOMICIN.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clostridium Difficile Infection
-
Vedanta Biosciences, Inc.CompletedClostridium Difficile Infection | Clostridium Difficile Infection Recurrence | Clostridium Difficile | CDI | Clostridioides Difficile Infection | Clostridioides Difficile | Clostridioides Difficile Infection RecurrenceUnited States, Canada
-
Vedanta Biosciences, Inc.Not yet recruitingClostridium Difficile Infection Recurrence | Recurrent Clostridium Difficile Infection | Clostridium Difficile | Diarrhea Infectious | CDI | Clostridium Difficile Infections | Clostridioides Difficile Infection | C.Difficile Diarrhea | Clostridioides Difficile Infection Recurrence | C. Diff Infection
-
University of PennsylvaniaTerminatedSevere Clostridium Difficile Infection | Severe-Complicated/Fulminant Clostridium Difficile InfectionUnited States
-
Mikrobiomik Healthcare Company S.L.CompletedRecurrent Clostridium Difficile Infection | Primary Clostridium Difficile InfectionSpain
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; North Carolina...CompletedClostridium DifficileUnited States
-
University Health Network, TorontoTerminatedRecurrent Clostridium Difficile Infection | Laboratory Confirmed Clostridium Difficile InfectionCanada
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitationClostridium Difficile Infection | Clostridium Difficile | C Difficile ColitisUnited States
-
Hospital Universitario Evangelico de CuritibaNot yet recruitingClostridium Difficile Infections
-
DeinoveRecruitingClostridium Difficile (C. Difficile)United States, Canada
-
MJM BontenUniversiteit Antwerpen; Universitätsklinikum Köln; Da VolterraCompletedClostridium DifficileGermany, Spain, France, Greece, Netherlands, Romania
Clinical Trials on Fidaxomicin
-
Astellas Pharma Europe B.V.Merck Sharp & Dohme LLCCompletedClostridium Difficile-associated Diarrhea (CDAD)United States, Belgium, Italy, Canada, France, Germany, Hungary, Poland, Romania, Spain
-
Astellas Pharma Europe Ltd.CompletedInflammatory Bowel Disease (IBD) | Clostridium Difficile Infection (CDI)Austria, France, Greece, Italy, Poland, Russian Federation, United Kingdom
-
Optimer Pharmaceuticals LLCCompletedClostridium Difficile-associated Diarrhea
-
Baylor College of MedicineCubist Pharmaceuticals LLCTerminatedSpinal Cord Injury | Clostridium DifficileUnited States
-
University of Colorado, DenverWithdrawnClostridium Difficile Infection | Solid Organ Transplant
-
Astellas Pharma S.A.S.Completed
-
Astellas Pharma IncCompleted
-
Optimer Pharmaceuticals LLCCompletedDiarrhea | Clostridium Infections
-
Optimer Pharmaceuticals LLCCompleted
-
University of AlbertaTerminatedClostridium DifficileCanada