Status:
UNKNOWN
Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years
Lead Sponsor:
RedHill Biopharma Limited
Conditions:
Traveler's Diarrhea
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
This will be a double blind comparative study, performed in pediatric subjects (Age 12-17) traveling to developing regions with a known high incidence of traveler's diarrhea. The subjects will be suff...
Detailed Description
Approximately 142 subjects are expected to be enrolled in the study, 1:1 in the Rifamycin SV MultiMatrix (MMX) plus Oral RehydrationTherapy (ORT) group and in the placebo tablets plus ORT group respec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04027894
Start Date
January 1 2024
End Date
December 1 2025
Last Update
January 27 2023
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