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

Primary Purpose

Traveler's Diarrhea

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rifamycin SV MMX
Placebo to Rifamycin SV-MMX
Sponsored by
RedHill Biopharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traveler's Diarrhea

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Rifamycin SV MMX plus ORT

    Placebo tablets plus ORT

    Arm Description

    Each tablet contains 200mg Rifamycin SV MMX for oral administration

    Placebo tablets identical to Rifamycin tablets with respect to size, taste and appearance.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Time to Last Unformed Stool (TLUS)
    defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared. Subjects who meet the criteria for clinical cure immediately after the start of the study and prior to passing any unformed stools are defined as having a TLUS of 0 hours. Subject who terminated the study early due treatment failure will have a censored TLUS set to 120 hours.
    Microbiological Cure
    the proportion of subjects with an identified pathogen at baseline with microbiological eradication in the post-treatment stool sample.
    Treatment Failure
    Defined as either of the following: Worsening diarrhea and/or signs or symptoms of enteric infection or failure to improve 24 hours or more after the first dose of study drug that results in administration of rescue therapy and/or Not achieving Clinical Cure in the 120-hr data collection period after the first dose of study drug or use of antimicrobial prohibited concomitant medication.
    Improvement
    Defined as ≥ 50% reduction in the number of unformed stools passing during a 24 h period, in comparison with the number of stools passed during the 24 h immediately before enrolment in the study.

    Full Information

    First Posted
    July 12, 2019
    Last Updated
    January 26, 2023
    Sponsor
    RedHill Biopharma Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04027894
    Brief Title
    Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years
    Official Title
    Double Blind Study to Evaluate the Safety and Efficacy of 400 mg Twice Daily Rifamycin SV MMX® Added to Standard Oral Rehydration Therapy (ORT) Versus Placebo Plus ORT, in the Treatment of Traveler's Diarrhea in Children Age 12 to 17 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RedHill Biopharma Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 suffering from acute diarrhea for at least 12 hours, without symptoms of systemic infection.
    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 respectively. The day of randomization (Visit 1, Day 1), the subjects will start the treatment receiving ORT plus Rifamycin SV MMX 400 mg (as two tablets of 200 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 × 200 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. Stool samples will be required in a subset population of the Rifamycin SV MMX group, at the Follow-up visit to determine rifamycin concentration in the feces. Blood and urine sampling for routine safety analyses will be collected at Visit 1 and at Visit 3.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traveler's Diarrhea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    142 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rifamycin SV MMX plus ORT
    Arm Type
    Experimental
    Arm Description
    Each tablet contains 200mg Rifamycin SV MMX for oral administration
    Arm Title
    Placebo tablets plus ORT
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablets identical to Rifamycin tablets with respect to size, taste and appearance.
    Intervention Type
    Drug
    Intervention Name(s)
    Rifamycin SV MMX
    Other Intervention Name(s)
    Rifamycin
    Intervention Description
    200 mg Rifamycin SV-MMX® (CB-01-11)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Rifamycin SV-MMX
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to Rifamycin SV-MMX® Placebo tablets correspond to active tablets with respect to size, taste, and appearance.
    Primary Outcome Measure Information:
    Title
    Clinical Cure
    Description
    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.
    Time Frame
    120 hours
    Secondary Outcome Measure Information:
    Title
    Time to Last Unformed Stool (TLUS)
    Description
    defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared. Subjects who meet the criteria for clinical cure immediately after the start of the study and prior to passing any unformed stools are defined as having a TLUS of 0 hours. Subject who terminated the study early due treatment failure will have a censored TLUS set to 120 hours.
    Time Frame
    120 hours
    Title
    Microbiological Cure
    Description
    the proportion of subjects with an identified pathogen at baseline with microbiological eradication in the post-treatment stool sample.
    Time Frame
    120 hours
    Title
    Treatment Failure
    Description
    Defined as either of the following: Worsening diarrhea and/or signs or symptoms of enteric infection or failure to improve 24 hours or more after the first dose of study drug that results in administration of rescue therapy and/or Not achieving Clinical Cure in the 120-hr data collection period after the first dose of study drug or use of antimicrobial prohibited concomitant medication.
    Time Frame
    120 hours
    Title
    Improvement
    Description
    Defined as ≥ 50% reduction in the number of unformed stools passing during a 24 h period, in comparison with the number of stools passed during the 24 h immediately before enrolment in the study.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gilead Raday, M.Sc.
    Phone
    +972-3-6398893
    Email
    gilead@redhillbio.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    June Almenoff, MD, PhD
    Organizational Affiliation
    RedHill Biopharma, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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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