Traveler's DiarrheaPhase 2NCT04027894
Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years
A Phase 2 study testing Rifamycin SV MMX in people with Traveler's Diarrhea, run by RedHill Biopharma Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Traveler's Diarrhea
- What is being tested?
- Rifamycin SV MMX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Traveler's Diarrhea
- Being tested
- Rifamycin SV MMX, Placebo to Rifamycin SV-MMX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifamycin SV MMXDrug
Also called Rifamycin
200 mg Rifamycin SV-MMX® (CB-01-11)
Placebo to Rifamycin SV-MMXDrug
Also called Placebo
Placebo to Rifamycin SV-MMX® Placebo tablets correspond to active tablets with respect to size, taste, and appearance.
| Study group | Role | What they receive |
|---|---|---|
| Rifamycin SV MMX plus ORT | Experimental | Each tablet contains 200mg Rifamycin SV MMX for oral administration Receives: Drug: Rifamycin SV MMX |
| Placebo tablets plus ORT | Placebo comparator | Placebo tablets identical to Rifamycin tablets with respect to size, taste and appearance. Receives: Drug: Placebo to Rifamycin SV-MMX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 hours
Secondary outcomes (4)
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.
Measured: 120 hours
Microbiological Cure
the proportion of subjects with an identified pathogen at baseline with microbiological eradication in the post-treatment stool sample.
Measured: 120 hours
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.
Measured: 120 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traveler's DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- June Almenoff, MD, PhD, Study director, RedHill Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027894
- Sponsor's protocol ID
- CB-01-11/30
- Status last verified
- Jan 2023
- First submitted
- 12 Jul 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04027894
- Acronym / sponsor ID
- CB-01-11/30
- Conditions
- Traveler's Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifamycin SV MMX plus ORT | Experimental | Drug: Rifamycin SV MMXEach tablet contains 200mg Rifamycin SV MMX for oral administration |
| Placebo tablets plus ORT | Placebo comparator | Drug: Placebo to Rifamycin SV-MMXPlacebo tablets identical to Rifamycin tablets with respect to size, taste and appearance. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifamycin SV MMXAlso: Rifamycin200 mg Rifamycin SV-MMX® (CB-01-11) | Drug | Rifamycin SV MMX plus ORT |
| Placebo to Rifamycin SV-MMXAlso: PlaceboPlacebo to Rifamycin SV-MMX® Placebo tablets correspond to active tablets with respect to size, taste, and appearance. | Drug | Placebo tablets plus ORT |
Primary outcome
Clinical Cure
Time frame: 120 hours
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.
4 secondary outcomes
Time to Last Unformed Stool (TLUS)
Time frame: 120 hours
Microbiological Cure
Time frame: 120 hours
Treatment Failure
Time frame: 120 hours
Improvement
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Almenoff, MD, PhD study director
RedHill Biopharma, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifamycin SV MMX in people with Traveler's Diarrhea, run by RedHill Biopharma Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilead Raday, M.Sc. (+972-3-6398893, gilead@redhillbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.