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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT01597505
Eligibility Criteria:
To be included in this study, participants must:
* Sign a consent form;
* Be \>= 18 and \< 90 years of age;
* Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
* Test positive for Clostridium difficile;
* If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.
Participants will not be allowed into the study if they:
* Have toxic megacolon and/or known small bowel ileus;
* Have received treatment with intravenous immune globulin (IVIG) within the past 30 days;
* Have received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
* Have received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
* Have received an investigational vaccine against C. difficile;
* Have received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
* Had more than 2 episodes of CDAD within 90 days;
* Had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy);
* Have history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
* Are unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
* Are unable to discontinue opiate treatment unless on a stable dose;
* Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
* Had stool studies positive for pathogenic ova and/or parasites;
* Have an intolerance or hypersensitivity to daptomycin and/or vancomycin;
* Have life-threatening illness at the time of enrollment;
* Have poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
* Have received an investigational drug or participated in any experimental procedure within 1 month;
* Have human immunodeficiency virus (HIV), a cluster of differentiation 4 (CD4) \< 200 cells/mm3 within 6 months of start of study therapy;
* Anticipate that certain antibacterial therapy for a non-CDAD infection will be required for \> 7 days;
* Are unable to discontinue Saccharomyces or similar probiotic;
* Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
* Are unable to comply with the protocol requirements;
* Have any condition that, in the opinion of the Investigator, might interfere;
* Are not expected to live for less than 8 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01597505
Study Brief:
Protocol Section:
NCT01597505