Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT02179658
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02179658
Study Brief:
Protocol Section:
NCT02179658