Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

NCT05597280 | Recruiting Phase 3 DMC

• 1 other identifier: BE-PEOPLE Phase 3
• Study Type: interventional
• Target: 124,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leprosy

Outcome Measures

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).

  Through study completion, an average of 4 years

Secondary Outcomes (6)

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

  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

  Until day 30 after treatment administration. 2026 final analyses

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

  Through study completion, an average of 4 years

• To monitor rifampicin and bedaquiline resistance among leprosy and tuberculosis patients

  Through study completion, an average of 4 years

• To assess cost-effectiveness of the BE-PEP regimen compared to SDR-PEP.

  Through study completion, an average of 4 years

Study Arms (2)

BE-PEP

EXPERIMENTAL

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; Drug: BE-PEP Rifampicin

SDR PEP

ACTIVE COMPARATOR

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

Interventions

BE-PEP Bedaquiline DRUG

bedaquiline

BE-PEP

SDR-PEP Rifampicin DRUG

SDR-PEP: rifampicin

SDR PEP

BE-PEP Rifampicin DRUG

BE-PEP rifampicin

BE-PEP

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Fondation Damien

Moroni, Comoros

RECRUITING

Related Publications (1)

• Younoussa A, Samidine SN, Bergeman AT, Piubello A, Attoumani N, Grillone SH, Braet SM, Tsoumanis A, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Snijders R, Corstjens P, Ortuno-Gutierrez N, Hoof C, Geluk A, de Jong BC, Hasker E. Protocol, rationale and design of BE-PEOPLE (Bedaquiline enhanced exposure prophylaxis for LEprosy in the Comoros): a cluster randomized trial on effectiveness of rifampicin and bedaquiline as post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2023 May 9;23(1):310. doi: 10.1186/s12879-023-08290-0.

  PMID: 37161571 DERIVED

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Younoussa Assoumani

  Damien Foundation Comoros

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolien Hoof

CONTACT

+32(0)32470716; choof@itg.be

Natacha Herssens

CONTACT

nherssens@itg.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 28, 2022
• Study Start: March 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CO (1)