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

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)

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).

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile
• Intervention / Treatment: Drug: OPT-80; Drug: vancomycin

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Chugoku, Japan
  • Hokkaido, Japan
  • Kanto, Japan
  • Kinnki, Japan
  • Kyushu, Japan
  • Touhoku, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPT-80 group; Oral	Drug: OPT-80; oral; Other Names: fidaxomicin
Active Comparator: Vancomycin group; Oral	Drug: vancomycin; oral

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2014
• Primary Completion (Actual): September 8, 2016
• Study Completion (Actual): September 8, 2016

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimated): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Vancomycin; Infections; Fidaxomicin; Clostridium; Difficile
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Diarrhea; Anti-Bacterial Agents; Anti-Infective Agents; Fidaxomicin; Vancomycin
• Other Study ID Numbers: 2819-CL-3002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.