Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
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|ClinicalTrials.gov Identifier: NCT02395848|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2015
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: Fidaxomicin||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open-label Trial to Evaluate Efficacy of 30-day Duration of Fidaxomicin in Patients With Recurrent C. Difficile Infection|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
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 Name: Dificid
- Clinical response at study day 30 [ 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.
- Time to resolution of diarrhea (TTROD [ Time Frame: 30 from the time of first dose of study medication to the time of resolution of diarrhea (in hours rounded up from minutes 30) ]
- Recurrence of CDI [ Time Frame: Time to diarrhea - assessed up to 8 weeks following completion of fidaxomicin ]defined by return of diarrhea (a minimum of 3 unformed bowel movements or 200 mL of stool for individuals with a stool collection device such as rectal tube or colostomy within a 24-hour period) and positive stool test after a period of symptom resolution within study period and has received at least a 10-day course of standard antibiotic therapy.
- Sustained clinical response [ 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395848
|Canada, British Columbia|
|Victoria, British Columbia, Canada, V8R 1J8|
|Principal Investigator:||Christine H Lee, MD||Vancouver Island Health Authority|