Clostridium Difficile
Conditions
Keywords
Clostridium, Infections, Difficile, Vancomycin, Fidaxomicin
Brief summary
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
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.
Interventions
DRUGOPT-80
oral
DRUGvancomycin
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global cure rate | Up to 38 days | 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 |
Secondary
| Measure | 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 |
| Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests | Up to 38 days |
| 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 |
| Plasma concentration of OPT-80(fidaxomicin) | Before administration, Day 1 and Day 10-11 |
Countries
Japan
Outcome results
None listed