Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

Launched by INSTITUTE OF TROPICAL MEDICINE, BELGIUM · Oct 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to prevent leprosy in people who live near someone diagnosed with the disease. There are two groups in the study: one group will receive a new treatment called BE-PEP, while the other group will receive the standard treatment recommended by the World Health Organization, which is a single dose of rifampicin. The goal is to see which treatment is more effective at reducing the risk of getting leprosy. The trial will start in 2023 and continue until 2026, with researchers tracking how many people in each group develop leprosy over time.

To be eligible for the trial, participants must be at least 2 years old and live in specific areas where the study is taking place. They should be in good health and not currently showing signs of leprosy or tuberculosis. If you join the study, you will receive either BE-PEP or the standard treatment, and there will be regular follow-ups to monitor your health. This study is important because it could lead to better prevention methods for leprosy, helping to protect people who are at risk.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
• • 2. 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.
• • 3. Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)
• Exclusion Criteria:
• • 1. Signs of active leprosy
• • 2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
• • 3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
• • 4. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
• • 5. Self-reported (suspected) pregnancy or breastfeeding
• • 6. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)