Official Title
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Phase
Phase 3Lead Sponsor
Institute of Tropical Medicine, BelgiumStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
LeprosyIntervention/Treatment
RifampicinStudy Participants
144000This 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.
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:
No Post-Exposure Prophylaxis (PEP) is given to anyone
PEP is given to all household contacts of incident leprosy cases
PEP is given to all people who live in a 100m radius of incident leprosy cases
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)
Rifampicin will be given in the same way to arms 2, 3 and 4 (weight dependent). Only the strategy of whom to offer PEP differs between the arms.
No PEP will be distributed
PEP will be given to all household contacts of an incident leprosy patient
PEP will be given to all household contacts of leprosy patients and to all other people living within a 100m radius of an incident leprosy patient.
PEP will be given to all household contacts of leprosy patients and to all other people living within a 100m radius of an incident leprosy patient who test positive in the UCP-LFA detecting anti-M. leprae PGL-I IgM Ab in fingerstick blood (anti-PGL-I)
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
