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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT02473393
Eligibility Criteria:
Inclusion Criteria:
* The patient provides written, informed consent before the clinical trial is initiated
* The patient has distinctive symptoms and findings of bacterial enteritis
* The patient has bacterial enteritis with one or more of the following causative pathogens either proven or presumed: C. difficile, Salmonella, Campylobacter, pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis
* The patient and his/her partner are willing to take contraceptive measures from initiation of investigational medicinal products (IMPs) to 4 weeks after administration of IMPs
Exclusion Criteria:
* The patient has severe or progressive underlying disease or complication, making it difficult to ensure safety in the study or proper efficacy assessment
* The patient has a current diagnosis or history of convulsive disorders, such as convulsion and epilepsy
* The patient has a severe hepatic dysfunction
* The patient has a severe cardiac dysfunction
* The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. Or the patient is treated with a drug reported to prolong QTc interval
* The patient has a moderate or severe renal dysfunction
* Women with confirmed or suspected pregnancy or breast-feeding women
* Patients judged to be ineligible by the investigator for any other reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
74 Years
Study:
NCT02473393
Study Brief:
Protocol Section:
NCT02473393