Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Child… (NCT04026984) | Clinical Trial Compass
UnknownPhase 2
Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years
142 participantsStarted 2024-06
Plain-language summary
This will be a double-blind comparative study, performed in pediatric subjects (Age 6-11) traveling to developing regions with a known high incidence of traveler's diarrhea. The subjects will be suffering from acute diarrhea for at least 12 hours, without symptoms of systemic infection.
Who can participate
Age range6 Years – 11 Years
SexALL
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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, 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 6-11 years of age, providing an unformed pre-treatment stool
* The parent or legally acceptable representative must provide informed consent for the subject. The Subject must also provide written informed assent and be accompanied 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
* 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 pathog…