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:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00304356
Eligibility Criteria:
Inclusion Criteria:
* Patient must be \> 18 years of age
* Clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis
* Diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces
* Disease has been treated, and the symptoms failed to respond to treatment with metronidazole or vancomycin, or symptoms promptly relapsed after completing a course of therapy with either of these drugs
* Able to take oral medication
Exclusion Criteria:
* Patients with other recognized causes of diarrhea or colitis
* Women of child bearing age who are pregnant, breast feeding, or not using birth control
* Patients taking coumadin, phenytoin, celecoxib, or losartan
* Patients with renal insufficiency (BUN or creatinine \>2 times baseline)
* Serious systemic disorder incompatible with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00304356
Study Brief:
Protocol Section:
NCT00304356