- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406479
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2) (BE-PEOPLE P2)
June 7, 2023 updated by: Institute of Tropical Medicine, Belgium
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study
This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros.
It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022.
This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial.
There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts.
The main study will be preceded by a phase 2 safety study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Given the fact that the investigators are going to provide to healthy people a drug that has not been used before for this indication and which has only been conditionally approved for use in multi-drug resistant tuberculosis, they have first foreseen a phase 2 study in which BE-PEP will be provided to a limited number of contacts and in which safety will be closely monitored and evaluated by an independent data and safety monitoring board (DSMB).
This will be done in a small village that is part arm 1 of the PEOPLE trial in which 8 new cases have been diagnosed since 2019 but no PEP has been provided.
The investigators will conduct door-to-door screening in this village in June 2022 and offer a single dose of BE-PEP to a random sample of 150 people screened aged 5 years and above not meeting the exclusion criteria (active tuberculosis (TB) or leprosy or previously treated leprosy, known liver function or cardiac abnormalities, not able to swallow 100 mg bedaquiline tablets).
Participants will be followed up closely with active monitoring for adverse events, including measurement of the corrected QT interval and liver function before and after administration, as well as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions.
The remainder of the population of this village aged two years and above will be offered single dose rifampicin as per WHO recommendations.
In a randomly sampled subset of 150 individuals receiving rifampicin only, the same stringent monitoring with ECG and liver function tests also applied in those receiving BE-PEP will be performed.
Study Type
Interventional
Enrollment (Actual)
321
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carolien Hoof
- Phone Number: +32(0)32470716
- Email: choof@itg.be
Study Contact Backup
- Name: Natacha Herssens
- Email: nherssens@itg.be
Study Locations
-
-
Anjouan
-
Gege, Anjouan, Comoros
- Fondation Damien
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being a permanent resident of the study village, in good state of health
- Able and willing to provide informed consent
- Age 5 years or above and weight of 20 kg or above
Exclusion Criteria:
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration)
- Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
- History of liver- or kidney disease
- Allergy to rifampicin or bedaquiline
- Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
- Not able to swallow bedaquiline 100 mg tablets
- Self-reported (suspected) pregnancy or breastfeeding
- Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)
- QT-prolongation of ≥450 msec in baseline ECG within the last week.
- Jaundice or self-reported liver function abnormalities or hepatitis
- Value of baseline ALT or AST >3x ULN within the last week. In case only ALT is available, this would suffice for enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
Eligible participants will receive one dose of Bedaquiline plus Rifampicin
|
Single dose of Bedaquiline
Single dose of Rifampicin
|
Active Comparator: SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
Eligible participants will receive one dose of Rifampicin (WHO recommendation)
|
Single dose of Rifampicin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean difference in QTc interval between the two arms 24 hours after treatment administration
Time Frame: 24 hours after treatment administration
|
Mean difference in QTc interval between the two arms 24 hours after treatment administration
|
24 hours after treatment administration
|
Occurence of any predetermined study stopping criteria, which will trigger an immediate pause on enrollment
Time Frame: Until day 30 after treatment administration
|
Occurence of any of the following predetermined study stopping criteria, which will trigger an immediate pause on enrollment:
|
Until day 30 after treatment administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline frequency of ALT in the population
Time Frame: At baseline
|
To determine the baseline frequency of ALT in the population.
|
At baseline
|
Baseline frequency of AST elevations in the population
Time Frame: At baseline
|
To determine baseline frequency of AST elevations in the population
|
At baseline
|
Baseline frequency of QTc prolongations in the population
Time Frame: At baseline
|
To determine baseline frequency of QTc prolongations in the population
|
At baseline
|
Post administration QTc prolongation
Time Frame: 24 hours after treatment administration
|
Post administration QTc prolongation
|
24 hours after treatment administration
|
Post-administration ALT level
Time Frame: Day 14 after treatment administration
|
Post administration ALT level
|
Day 14 after treatment administration
|
Post-administration AST level
Time Frame: Day 14 after treatment administration
|
Post-administration AST level
|
Day 14 after treatment administration
|
Frequency of potentially common adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions
Time Frame: Until day 30 after treatment administration
|
Frequency of potentially common adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions
|
Until day 30 after treatment administration
|
Occurrence of any (serious)AEs
Time Frame: Until day 30 after treatment administration
|
Occurrence of any (serious)AEs
|
Until day 30 after treatment administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Younoussa Assoumani, Damien Foundation Comoros
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2022
Primary Completion (Actual)
January 26, 2023
Study Completion (Actual)
January 26, 2023
Study Registration Dates
First Submitted
May 20, 2022
First Submitted That Met QC Criteria
June 2, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Actual)
June 12, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE-PEOPLE Phase 2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leprosy
-
Paul SaundersonCompletedLepromatous Leprosy | Borderline Lepromatous LeprosyPhilippines
-
Janssen Research & Development, LLCCompletedLeprosy, MultibacillaryBrazil
-
Federal University of UberlandiaUnknownLeprosy NeuropathyBrazil
-
Eijkman Oxford Clinical Research Unit, IndonesiaLondon School of Hygiene and Tropical Medicine; Radboud University Medical... and other collaboratorsRecruitingLeprosy | Leprosy, Multibacillary | Neglected Tropical DiseasesIndonesia
-
Yunia IrawatiCompletedParalytic Lagophthalmos | Leprosy--PatientsIndonesia
-
Yohanes Firmansyah, dr, MH, MMTarumanagara UniversityCompletedCM-MSC ; Stem Cell ; Trophic Ulcer ; Leprosy ; Morbun Hansen; SecretomIndonesia
-
University of Sao PauloCristália Produtos Químicos Farmacêuticos Ltda.Active, not recruitingLeprosy | Pain, Neuropathic | Leprosy Neuropathy | AmitriptylineBrazil
-
London School of Hygiene and Tropical MedicineArmauer Hansen Research Institute, Ethiopia; Alert Hospital, Ethiopia; Homes...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on BE-PEP (Bedaquiline)
-
Institute of Tropical Medicine, BelgiumRecruiting
-
University Hospital, BrestCompletedChronic Obstructive Pulmonary Disease | Patients Hospitalized for a COPD ExacerbationFrance
-
Cliniques universitaires Saint-Luc- Université...Unknown
-
Centers for Disease Control and PreventionUniversity of Illinois, Center on Health Promotion Research for Persons with...CompletedObesityUnited States
-
Linkoeping UniversityCompletedAcute Respiratory Distress Syndrome
-
DSM Food SpecialtiesCompleted
-
Christopher J. McLeodRion LLCEnrolling by invitationPercutaneous Coronary InterventionUnited States
-
University Medical Center GroningenNot yet recruiting
-
Cliniques universitaires Saint-Luc- Université...CompletedPulmonary Disease, Chronic ObstructiveBelgium
-
Hospital de GranollersCompleted