Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (BE-PEOPLE P3)
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ClinicalTrials.gov Identifier: NCT05597280 |
Recruitment Status :
Recruiting
First Posted : October 28, 2022
Last Update Posted : September 14, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leprosy | Drug: BE-PEP Bedaquiline Drug: SDR-PEP Rifampicin Drug: BE-PEP Rifampicin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 124000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study |
Actual Study Start Date : | March 22, 2023 |
Estimated Primary Completion Date : | December 31, 2026 |
Estimated Study Completion Date : | December 31, 2026 |
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. |
Drug: BE-PEP Bedaquiline
bedaquiline Drug: BE-PEP Rifampicin 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. |
Drug: SDR-PEP Rifampicin
SDR-PEP: rifampicin |
- 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).
- 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.
- 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.
- 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
- 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.
- 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.
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Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05597280
Contact: Carolien Hoof | +32(0)32470716 | choof@itg.be | |
Contact: Natacha Herssens | nherssens@itg.be |
Comoros | |
Fondation Damien | Recruiting |
Moroni, Comoros | |
Contact: Younoussa Assoumani yaoussaoumani@gmail.com |
Principal Investigator: | Younoussa Assoumani | Damien Foundation Comoros |
Responsible Party: | Institute of Tropical Medicine, Belgium |
ClinicalTrials.gov Identifier: | NCT05597280 |
Other Study ID Numbers: |
BE-PEOPLE Phase 3 |
First Posted: | October 28, 2022 Key Record Dates |
Last Update Posted: | September 14, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Leprosy Mycobacterium Infections, Nontuberculous Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Rifampin Bedaquiline Antibiotics, Antitubercular Antitubercular Agents |
Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |