Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2023-01-17

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Leprosy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A cluster randomized trial in which villages are assigned to one of four intervention groups

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No PEP

No PEP will be distributed

Group Type NO_INTERVENTION

No interventions assigned to this group

Household PEP

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

Group Type OTHER

Rifampicin

Intervention Type DRUG

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.

PEP 100m

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.

Group Type EXPERIMENTAL

Rifampicin

Intervention Type DRUG

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.

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

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)

Group Type OTHER

Rifampicin

Intervention Type DRUG

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.

Interventions

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Rifampicin

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes