Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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 suffering from acute diarrhea for at least 12 hours, without symptoms of systemic infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cosmo Technologies Ltd; RedHill Biopharma Limited
• Treatments: Rifamycin SV; Rifamycins

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