A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Cl… (NCT02179658) | Clinical Trial Compass
CompletedPhase 3
A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Japan210 participantsStarted 2014-06-23
Plain-language 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).
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.