Health Trials

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

ConditionLeprosy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorInstitute of Tropical Medicine, Belgium

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Signs of active leprosy

Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BE-PEP Bedaquiline

    Drug

    bedaquiline

  • SDR-PEP Rifampicin

    Drug

    SDR-PEP: rifampicin

  • BE-PEP Rifampicin

    Drug

    BE-PEP rifampicin

Treatment groups

124,000 Participants
are divided into 2 treatment groups
Group A: BE-PEPExperimental treatment 2 interventions
Group B: SDR PEPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate effectiveness of PEP based on a combination of rifampicin and bedaquiline (BE-PEP), in preventing leprosy among contacts of incident cases.

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).

Time frame
Through study completion, an average of 4 years

Secondary outcomes

1

To assess effectiveness of the BE-PEP regimen at village level.

The incidence rate ratio between villages that received BE-PEP and villages that received SDR-PEP.

Time frame
Through study completion, an average of 4 years
2

To quantify frequency of potential adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions

The proportion of participants treated with BE-PEP that report adverse events, with a breakdown by type of event.

Time frame
Until day 30 after treatment administration. 2026 final analyses
3

To assess anti-PGL-I sero surveys as a tool to monitor leprosy transmission

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

Time frame
Through study completion, an average of 4 years
4

To monitor rifampicin and bedaquiline resistance among leprosy and tuberculosis patients

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.

Time frame
Through study completion, an average of 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Tropical Medicine, Belgium

Lead sponsor

Source ClinicalTrials.gov
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