A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Study Overview
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Brief Summary
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The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Detailed Description
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This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.

Official Title
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OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

Conditions
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Clostridium Difficile

Intervention / Treatment
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* Drug: OPT-80
* Drug: vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients who have symptoms of CDAD as defined by; (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and (2)Presence of either toxin A and/or B of C. difficile in the stool Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study Exclusion Criteria: Life-threatening or fulminant CDAD Ileus paralytic or toxic megacolon Likelihood of death before the completion of study from any cause Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent Subjects who in the opinion of the investigator require other drugs to control diarrhea Need of change in dosage regimen of opiates during the study period Need of change in dosage regimen of probiotic products during the study period History/complications of ulcerative colitis or Crohn's disease Multiple occurrences of CDAD within the past three months Hypersensitivity to vancomycin Previous exposure to OPT-80 (fidaxomicin) Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study Participation in other clinical research studies or Post Marketing Clinical Trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPT-80 group<br>Oral | Drug: OPT-80<br>* oral<br>* Other names: fidaxomicin;|
| Active Comparator: Vancomycin group<br>Oral | Drug: vancomycin<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cure rate | Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period | Up to 38 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate |  | Day 10 -11 of the study period | 
| Recurrence rate of CDAD |  | during the 4-week follow-up period, up to Day 38 | 
| Time to resolution of diarrhea |  | up to 38 days | 
| Microbiological efficacy |  | Up to 38 days | 
| Plasma concentration of OPT-80(fidaxomicin) |  | Before administration, Day 1 and Day 10-11 | 
| Plasma concentration of OP-1118 |  | Before administration, Day 1 and Day 10-11 | 
| Fecal concentration of OPT-80(fidaxomicin) |  | Day 10-11 | 
| Fecal concentration of OP-1118 |  | Day 10-11 | 
| Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests |  | Up to 38 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium, Infections, Difficile, Vancomycin, Fidaxomicin