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

NCT02179658 | Completed Phase 3

• 1 other identifier: 2819-CL-3002
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 7

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).

Conditions

Clostridium Difficile

Keywords

Clostridium; Infections; Difficile; Vancomycin; Fidaxomicin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

OPT-80 group

EXPERIMENTAL

Oral

Drug: OPT-80

Vancomycin group

ACTIVE COMPARATOR

Oral

Drug: vancomycin

Interventions

OPT-80 DRUG

oral

Also known as: fidaxomicin

OPT-80 group

vancomycin DRUG

oral

Vancomycin group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (7)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kinnki, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (1)

• 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.

  PMID: 29934056 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Infections

Interventions

OPT 80; Fidaxomicin; Vancomycin

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: June 23, 2014
• Primary Completion: September 8, 2016
• Study Completion: September 8, 2016
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)