Clinical Trials Logo

Clinical Trial Summary

There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.


Clinical Trial Description

Assuming the phase 2 study will not reveal any drug related adverse events and following the advice of the DSMB and the involved ethics committees, the investigators will proceed with a phase 3 study for which randomization will take place in December, 2022. There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the 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. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the overall leprosy incidence over the follow-up period will be compared between the two study arms. As stated above, the primary outcome measure will be the incidence rate ratio of leprosy between those who received BE-PEP and those who received the standard SDR-PEP. From this analysis the investigators will exclude those not eligible for BE-PEP, i.e. children below 5 years of age and/or with a weight below 20 kg. A Poisson model will be fit with village nested in island as random effect and controlled for distance to the nearest index case at baseline. In addition the investigators will compute incidence rate ratios between the entire BE-PEP and SDR-PEP arms over the period 2023-2026, also based on a Poisson model with village nested in island as random effect. Throughout the BE-PEOPLE trial the investigators will continue sampling leprosy patients identified (a skin biopsy from the edge of non-facial lesions), with the aim of using molecular assays for M. leprae as quality assurance mechanism. If sufficient DNA is available Deeplex-MycLep will be used for typing the strains, which will allow to perform highly sensitive surveillance for (traces of) resistance to rifampicin and bedaquiline. As part of BE-PEOPLE, the investigators will moreover enroll all microbiologically confirmed tuberculosis patients on all islands of Comoros (Moheli, Anjouan, and Grande Comore, where bedaquiline will not be introduced, maximum 100 patients/ year) and assess whether they ever received (BE-)PEP or leprosy treatment. The investigators will genotype their sputum with Deeplex-MycTB XL, which includes all M. tuberculosis genes (potentially) involved in resistance to rifampicin and bedaquiline, to be able to detect the earliest traces of acquired resistance to these drugs, which is unexpected after single dose administration.The overall goal of BE-PEOPLE is to validate a robust and safe leprosy PEP regimen, and its optimal administration, that prevents leprosy in the individual and interrupts transmission at the village level.If BE-PEP turns out to be safe and successful, the investigators aim to adjust national guidelines in Comoros towards island wide implementation on Anjouan and Moheli, allowing to sustainably eliminate leprosy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05597280
Study type Interventional
Source Institute of Tropical Medicine, Belgium
Contact Carolien Hoof
Phone +32(0)32470716
Email choof@itg.be
Status Recruiting
Phase Phase 3
Start date March 22, 2023
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT03302897 - Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers Phase 1
Recruiting NCT05243654 - Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy Phase 2
Completed NCT05091216 - The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients N/A
Completed NCT00860717 - The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients N/A
Recruiting NCT06222372 - Novel Interventions and Diagnostic Tests for Leprosy N/A
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Terminated NCT01751503 - Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer N/A
Active, not recruiting NCT03324035 - Treatment of Neuropathic Pain in Leprosy Phase 3
Completed NCT03683745 - Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
Recruiting NCT02550080 - Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome Phase 4
Completed NCT02484469 - Impact of the Virtual Human Project on Team-based Learning: A Randomized-controlled Trial N/A
Completed NCT01165840 - Effect of Weight and/or Obesity on Dapsone Drug Concentrations Phase 4
Completed NCT00919542 - Ciclosporin in the Management of New Erythema Nodosum Leprosum Phase 2
Completed NCT05406479 - Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2) Phase 2
Recruiting NCT03807362 - CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum Phase 2
Completed NCT01006759 - Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients Phase 1
Completed NCT03662022 - Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar Phase 3
Completed NCT01920750 - Leprosy Skin Test Antigens Phase 1 Phase 1
Recruiting NCT06416033 - Serum Irisin Level In Leprosy Patients
Not yet recruiting NCT03947437 - Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients Phase 1/Phase 2