Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years

RedHill Biopharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Traveler's Diarrhea

Treatments: Drug: Placebo; Drug: Rifamycin SV-MMX

Study type: Interventional

Funder types: Industry

Identifiers

NCT04026984

CB-01-11/29

Details and patient eligibility

About

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.

Full description

Approximately 142 subjects are expected to be enrolled in the study, 1:1 in the Rifamycin SV MultiMatrix (MMX) plus Oral Rescue Therapy (ORT) group and in the placebo tablets plus ORT group respectively. The day of randomization (Visit 1, Day 1), the subjects will start the treatment receiving ORT plus Rifamycin SV MMX 100 mg (as two tablets of 50 mg each) twice daily (morning and evening) or ORT plus placebo tablets (as two tablets) twice daily (morning and evening). The subjects will begin the treatment within 72 hours of onset of diarrhea. Treatment duration will last 72 hours. The total number of tablets for the entire treatment course will be 12 (4 × 50 mg tablets/day for 3 days). The administration of the ORT will follow the specification reported in the product label. The tablets will be orally administered during the day. No tablet administration will be done during the night.

After enrollment, subjects/their parents/or guardians will complete Diary cards (PDC) in which will be daily recorded date, time of first tablets intake, time and consistency of each stool, presence of blood in stools, abdominal pain/cramps, flatulence, tenesmus, urgency, nausea, vomiting, fever, adverse events (AEs), and concomitant medications.

During the study, the subjects will be assessed for safety and efficacy at Visit 2 (Day 2) and Visit 3 (Day 4/5) as final Study Visit.

Stool samples for microbiological assessment will be collected at Visits 1 and 3. Stool will be examined and cultured at local labs for main enteropathogens and for the presence of protozoa, ova and yeasts.

Blood and urine sampling for routine safety analyses will be collected at Visit 1 and at Visit 3.

Enrollment: 142 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

142 participants in 2 patient groups, including a placebo group

Rifamycin SV MMX plus ORT

Experimental group

Description:

One tablet contains 50 mg Rifamycin SV-MMX® plus standard of care Oral Rehydration Therapy (ORT). Two 50mg tablets will be administered twice daily.

Treatment:

Drug: Rifamycin SV-MMX

Placebo tablets plus ORT

Placebo Comparator group

Description:

Matching placebo tablets plus standard of care Oral Rehydration Therapy (ORT)

Treatment:

Drug: Placebo