Clinical trial NCT02179658: A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Difficile
Keywords: Clostridium
Infections
Difficile
Vancomycin
Fidaxomicin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global cure rate
timeFrame: Up to 38 days
Secondary outcomes:
measure: Cure rate
timeFrame: Day 10 -11 of the study period
measure: Recurrence rate of CDAD
timeFrame: during the 4-week follow-up period, up to Day 38
measure: Time to resolution of diarrhea
timeFrame: up to 38 days
measure: Microbiological efficacy
timeFrame: Up to 38 days
measure: Plasma concentration of OPT-80(fidaxomicin)
timeFrame: Before administration, Day 1 and Day 10-11
measure: Plasma concentration of OP-1118
timeFrame: Before administration, Day 1 and Day 10-11
measure: Fecal concentration of OPT-80(fidaxomicin)
timeFrame: Day 10-11
measure: Fecal concentration of OP-1118
timeFrame: Day 10-11
measure: Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests
timeFrame: Up to 38 days
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kanto
country: Japan
city: Kinnki
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Mikamo H, Tateda K, Yanagihara K, Kusachi S, Takesue Y, Miki T, Oizumi Y, Gamo K, Hashimoto A, Toyoshima J, Kato K. Efficacy and safety of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in a randomized, double-blind, comparative Phase III study in Japan. J Infect Chemother. 2018 Sep;24(9):744-752. doi: 10.1016/j.jiac.2018.05.010. Epub 2018 Jun 19.