- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05597280
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (BE-PEOPLE P3)
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
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
-
-
-
Moroni, Comoros
- Recruiting
- Fondation Damien
-
Contact:
- Younoussa Assoumani
- Email: yaoussaoumani@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
- Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.
- Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)
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)
- Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
- 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)
Study Plan
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
Intervention arm in which BE-PEP will be provided to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. BE-PEP: bedaquiline (400 or 800 mg depending on weight band) combined with rifampicin (10 mg/kg) will be provided as post-exposure prophylaxis Both arms will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg, for bedaquiline it's 20 mg or 100 mg. |
bedaquiline
BE-PEP rifampicin
|
Active Comparator: SDR PEP
WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg. |
SDR-PEP: rifampicin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate effectiveness of PEP based on a combination of rifampicin and bedaquiline (BE-PEP), in preventing leprosy among contacts of incident cases.
Time Frame: Through study completion, an average of 4 years
|
The incidence rate ratio of leprosy between contacts who received the trial regimen (BE-PEP: rifampicin 600 mg plus bedaquiline 800mg, repeated once after four weeks for household contacts) and those who received the WHO standard prophylactic regimen (SDR-PEP: rifampicin 600 mg, single dose).
|
Through study completion, an average of 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess effectiveness of the BE-PEP regimen at village level.
Time Frame: Through study completion, an average of 4 years
|
The incidence rate ratio between villages that received BE-PEP and villages that received SDR-PEP.
|
Through study completion, an average of 4 years
|
To quantify frequency of potential adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions
Time Frame: Until day 30 after treatment administration. 2026 final analyses
|
The proportion of participants treated with BE-PEP that report adverse events, with a breakdown by type of event.
|
Until day 30 after treatment administration. 2026 final analyses
|
To assess anti-PGL-I sero surveys as a tool to monitor leprosy transmission
Time Frame: Through study completion, an average of 4 years
|
anti-PGL-I sero prevalence rates in villages belonging to arm 4 of the original PEOPLE trial at the time of the first survey round in 2019 and the final round of BE-PEOPLE in 2026
|
Through study completion, an average of 4 years
|
To monitor rifampicin and bedaquiline resistance among leprosy and tuberculosis patients
Time Frame: Through study completion, an average of 4 years
|
The investigators will quantify the prevalence of rifampicin and/or bedaquiline resistant strains of M. leprae and M. tuberculosis on each of the study islands making use of molecular markers.
|
Through study completion, an average of 4 years
|
To assess cost-effectiveness of the BE-PEP regimen compared to SDR-PEP.
Time Frame: Through study completion, an average of 4 years
|
Cost per case averted between BE-PEP arm and SDR-PEP.
|
Through study completion, an average of 4 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Younoussa Assoumani, Damien Foundation Comoros
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Mycobacterium Infections, Nontuberculous
- Leprosy
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Rifampin
- Bedaquiline
Other Study ID Numbers
- BE-PEOPLE Phase 3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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