Clinical trial NCT03662022: Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Official title: Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leprosy
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Damien Foundation
name: Centre d'Infectiologie Charles Mérieux
name: Fondation Raoul Follereau
name: Leiden University Medical Center
name: L'Institut National de la Santé et de la Recherche Médicale
name: Genoscreen
name: Instituto Fernandes Figueira
First posted: 2018-09-07
Enrollment: 144000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized trial in which villages are assigned to one of four intervention groups
Primary purpose: PREVENTION

Brief summary: This is a cluster randomized trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar.

The study aims to identify which approach to the selection of contacts for post exposure prophylaxis is most effective to reduce incident leprosy, and to Interrupt ongoing transmission from asymptomatic persons in the process of developing multibacillary leprosy.

Detailed description: For the purpose of the study, villages on the Comoros and Madagascar that will be randomly assigned to one of the study arms, will be screened on a yearly basis for 4 consecutive years. Depending on which of the 4 arms a village is assigned to, people in the surroundings of a leprosy patient will or will not be offered Post-Exposure Prophylaxis (PEP) using rifampicin at 20mg/kg single dose:

1. No Post-Exposure Prophylaxis (PEP) is given to anyone
2. PEP is given to all household contacts of incident leprosy cases
3. PEP is given to all people who live in a 100m radius of incident leprosy cases
4. PEP is given to all household contacts of incident leprosy cases as well as to all others who live within a 100m radius of an incident leprosy case and test positive in the UCP-LFA detecting anti-M. leprae PGL-I IgM antibodies (Ab) in fingerstick blood (anti-PGL-1)

Eligibility criteria: Inclusion Criteria:

* Living in one of the study villages
* Aged 2 years and above
* Able and willing to provide informed consent

Exclusion Criteria:

* Signs of active leprosy (\*)
* Signs of active pulmonary tuberculosis (cough ≥2 weeks duration) (\*)
* Having received Rifampicin within the last 24 months (\*)

(\*) These people may still be included for yearly leprosy screening, but will be excluded to receive PEP

Primary outcomes:
measure: Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis
timeFrame: 45 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anjouan
country: Comoros
facility: Damien Foundation
city: Mohéli
country: Comoros
facility: Damien Foundation
city: Miandrivazo
country: Madagascar
facility: Fondation Raoul Follereau
state: Menabe
Study officials:
affiliation: Institute of Tropical Medicine
name: Bouke de Jong, MD, PhD
role: STUDY_CHAIR
affiliation: Institute of Tropical Medicine
name: Epco Hasker, MD
role: STUDY_DIRECTOR
affiliation: Damien Foundation
name: Younoussa Assoumani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Raoul Follereau
name: Bertrand Cauchoix, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortuno-Gutierrez N, Younoussa A, Randrianantoandro A, Braet S, Cauchoix B, Ramboarina S, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Richardus JH, de Jong BC, Hasker E. Protocol, rationale and design of PEOPLE (Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar): a cluster randomized trial on effectiveness of different modalities of implementation of post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2019 Dec 5;19(1):1033. doi: 10.1186/s12879-019-4649-0.