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

June 30, 2023 updated by: Institute of Tropical Medicine, Belgium

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

144000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Anjouan, Comoros
        • Damien Foundation
      • Mohéli, Comoros
        • Damien Foundation
    • Menabe
      • Miandrivazo, Menabe, Madagascar
        • Fondation Raoul Follereau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No PEP
No PEP will be distributed
Other: Household PEP
PEP will be given to all household contacts of an incident leprosy patient
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.
Experimental: 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.
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.
Other: 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare effectiveness in curbing transmission of leprosy of three different approaches of post exposure prophylaxis
Time Frame: 45 months
Three incidence rate ratios between the comparator arm (arm 1) and each of the three intervention arms. These ratios will be based on incidence rates measured between the first and fourth household survey in each of the intervention arms, always divided by that of the comparator arm.
45 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess cost and feasibility of SDDR-PEP under program conditions
Time Frame: 45 months
Costs will be calculated per person screened, per person treated with SDDR-PEP and per leprosy case averted.
45 months
Identify patterns of clustering in transmission of leprosy, allowing better targeting of control measures
Time Frame: 45 months
We will quantify the degree of clustering as the average proportion of leprosy cases belonging to a same phylogenetic cluster by village. Geographic clustering will also be assessed by calculating risk ratios for being diagnosed with leprosy as a function of geographic distance from incident cases diagnosed earlier in each of the four arms
45 months
Monitor rifampicin resistance among leprosy patients
Time Frame: 45 months
We will quantify prevalence of Rifampicin resistant strains of M. leprae on each of the study islands making use of molecular markers
45 months
Estimate incidence and prevalence of smear positive pulmonary tuberculosis in the study villages
Time Frame: 45 months
During door-to-door surveys for leprosy we will enquire about chronic cough and screen for pulmonary tuberculosis if indicated. Prevalence of pulmonary tuberculosis will be calculated per island based on the results of the baseline survey, using as denominator the total population screened on the island. After each survey round annual incidence rates will be calculated based on the results of the follow-up surveys
45 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Bouke de Jong, MD, PhD, Institute of Tropical Medicine
  • Study Director: Epco Hasker, MD, Institute of Tropical Medicine
  • Principal Investigator: Younoussa Assoumani, MD, Damien Foundation
  • Principal Investigator: Bertrand Cauchoix, MD, Fondation Raoul Follereau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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