Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar (PEOPLE)

Institute of Tropical Medicine, Belgium

Status and phase: Completed; Phase 3

Conditions: Leprosy

Treatments: Drug: Rifampicin

Study type: Interventional

Funder types: Other

Identifiers

NCT03662022

1248/18

Details and patient eligibility

About

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.

Full 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)

Enrollment: 144,000 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144,000 participants in 4 patient groups

No PEP

No Intervention group

Description:

No PEP will be distributed

Household PEP

Other group

Description:

PEP will be given to all household contacts of an incident leprosy patient

Treatment:

Drug: Rifampicin

PEP 100m

Experimental group

Description:

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.

Treatment:

Drug: Rifampicin

PEP 100m + positive for anti-PGL-I IgM Ab

Other group

Description:

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)

Treatment:

Drug: Rifampicin