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

NCT04026984 | Unknown Phase 2 FDA Drug

• 1 other identifier: CB-01-11/29
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Traveler's Diarrhea

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Passage of two or fewer soft stools and no watery stools, no fever (\> 100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24-hour interval in the 120-hour data collection period after the first dose of study drug or Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hour data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection.

  120 hours

Secondary Outcomes (3)

• Time to last unformed stool (TLUS)

  120 hours

• Microbiological Cure

  120 hours

• Treatment Failure

  120 hours

Study Arms (2)

Rifamycin SV MMX plus ORT

EXPERIMENTAL

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

Drug: Rifamycin SV-MMX

Placebo tablets plus ORT

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rifamycin SV-MMX DRUG

2 Rifamycin SV-MMX® 50 mg tablets b.i.d. plus ORT

Also known as: Rifamycin

Rifamycin SV MMX plus ORT

Placebo DRUG

Matching Placebo tablets

Placebo tablets plus ORT

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RedHill Biopharma Limited: lead

MeSH Terms

Interventions

rifamycin SV

Study Officials

• June Almenoff, MD, PhD

  RedHill Biopharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Gilead Raday

CONTACT

+972-3-6398893; gilead@redhillbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 19, 2019
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2023

Record last verified: 2023-01