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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT04027894
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute bacterial diarrhea defined as at least 3 unformed stools within the 24 hours preceding randomization, with a duration of illness ≤72 h. The bacterial origin of diarrhea will be confirmed "a posteriori" by stool microbiology sampling at the time of screening.
* Presence of one or more signs or symptoms of enteric infection have to be present, including nausea, vomiting, abdominal cramps or pain, tenesmus, urgency
* History of recent travel from an industrialized country to a developing region with a known high incidence of travelers' diarrhea
* Male or female 12-17 years of age, providing an unformed pre-treatment stool
* Females of child-bearing potential must use an acceptable contraceptive method throughout the study treatment period
* The parent or legally acceptable representative guardian must provide informed consent for the subject. The Subject must also provide written informed assent by the parent or legal guardian at the time of assent/consent signing.
Exclusion Criteria:
* Fever (\>100.4ºF or 38ºC), or presence of signs and symptoms of systemic infection
* Females pregnant or breast feeding or not using adequate birth control
* Known or suspected infection with non-bacterial pathogen
* Symptoms of acute diarrhea of \>72 hours duration
* Presence of grossly bloody stool
* Moderate to severe dehydration
* History of inflammatory bowel disease (IBD)
* Abdominal ileus
* Severe dehydration
* Greater than two doses of an antidiarrheal medication within 24 hours before randomization, or any symptomatic therapy within 2 hours before enrolment
* Receiving antimicrobial drug with expected activity against enteric bacterial pathogens within the week prior to enrolment
* Hypersensitivity to rifamycin-related antibiotics or to any excipient included in the study medications
* Subjects unable/unwilling to comply with study protocol
* Participation in a clinical trial within the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT04027894
Study Brief:
Protocol Section:
NCT04027894