For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 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.
  2. Presence of one or more signs or symptoms of enteric infection have to be present, including nausea, vomiting, abdominal cramps or pain, tenesmus, urgency
  3. History of recent travel from an industrialized country to a developing region with a known high incidence of travelers' diarrhea
  4. Male or female 12-17 years of age, providing an unformed pre-treatment stool
  5. Females of child-bearing potential must use an acceptable contraceptive method throughout the study treatment period
  6. 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

  1. Fever (>100.4ºF or 38ºC), or presence of signs and symptoms of systemic infection
  2. Females pregnant or breast feeding or not using adequate birth control
  3. Known or suspected infection with non-bacterial pathogen
  4. Symptoms of acute diarrhea of >72 hours duration
  5. Presence of grossly bloody stool
  6. Moderate to severe dehydration
  7. History of inflammatory bowel disease (IBD)
  8. Abdominal ileus
  9. Severe dehydration
  10. Greater than two doses of an antidiarrheal medication within 24 hours before randomization, or any symptomatic therapy within 2 hours before enrolment
  11. Receiving antimicrobial drug with expected activity against enteric bacterial pathogens within the week prior to enrolment
  12. Hypersensitivity to rifamycin-related antibiotics or to any excipient included in the study medications
  13. Subjects unable/unwilling to comply with study protocol
  14. Participation in a clinical trial within the last 30 days
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +972-3-6398893Email iconEmail Study Center

Study’s details


Contition

Traveler's Diarrhea

Age

12+

Phase

Phase 2

Participants needed

142

Est. Completion Date

Dec 2025

Treatment type

Interventional


Sponsor

RedHill Biopharma Limited

ClinicalTrials.gov identifier

NCT04027894

Study number

CB-01-11/30

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