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

Primary Purpose

Leprosy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rifampicin
Sponsored by
Institute of Tropical Medicine, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leprosy

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Damien Foundation
  • Damien Foundation
  • Fondation Raoul Follereau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Other

Experimental

Other

Arm Label

No PEP

Household PEP

PEP 100m

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

Arm Description

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)

Outcomes

Primary Outcome Measures

Compare effectiveness in curbing transmission of leprosy of three different approaches of post exposure prophylaxis
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.

Secondary Outcome Measures

Assess cost and feasibility of SDDR-PEP under program conditions
Costs will be calculated per person screened, per person treated with SDDR-PEP and per leprosy case averted.
Identify patterns of clustering in transmission of leprosy, allowing better targeting of control measures
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
Monitor rifampicin resistance among leprosy patients
We will quantify prevalence of Rifampicin resistant strains of M. leprae on each of the study islands making use of molecular markers
Estimate incidence and prevalence of smear positive pulmonary tuberculosis in the study villages
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

Full Information

First Posted
September 5, 2018
Last Updated
June 30, 2023
Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Damien Foundation, Centre d'Infectiologie Charles Mérieux, Fondation Raoul Follereau, Leiden University Medical Center, L'Institut National de la Santé et de la Recherche Médicale, Genoscreen, Instituto Fernandes Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT03662022
Brief Title
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Acronym
PEOPLE
Official Title
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Damien Foundation, Centre d'Infectiologie Charles Mérieux, Fondation Raoul Follereau, Leiden University Medical Center, L'Institut National de la Santé et de la Recherche Médicale, Genoscreen, Instituto Fernandes Figueira

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A cluster randomized trial in which villages are assigned to one of four intervention groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No PEP
Arm Type
No Intervention
Arm Description
No PEP will be distributed
Arm Title
Household PEP
Arm Type
Other
Arm Description
PEP will be given to all household contacts of an incident leprosy patient
Arm Title
PEP 100m
Arm Type
Experimental
Arm 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.
Arm Title
PEP 100m + positive for anti-PGL-I IgM Ab
Arm Type
Other
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare effectiveness in curbing transmission of leprosy of three different approaches of post exposure prophylaxis
Description
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.
Time Frame
45 months
Secondary Outcome Measure Information:
Title
Assess cost and feasibility of SDDR-PEP under program conditions
Description
Costs will be calculated per person screened, per person treated with SDDR-PEP and per leprosy case averted.
Time Frame
45 months
Title
Identify patterns of clustering in transmission of leprosy, allowing better targeting of control measures
Description
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
Time Frame
45 months
Title
Monitor rifampicin resistance among leprosy patients
Description
We will quantify prevalence of Rifampicin resistant strains of M. leprae on each of the study islands making use of molecular markers
Time Frame
45 months
Title
Estimate incidence and prevalence of smear positive pulmonary tuberculosis in the study villages
Description
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
Time Frame
45 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bouke de Jong, MD, PhD
Organizational Affiliation
Institute of Tropical Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Epco Hasker, MD
Organizational Affiliation
Institute of Tropical Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Younoussa Assoumani, MD
Organizational Affiliation
Damien Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertrand Cauchoix, MD
Organizational Affiliation
Fondation Raoul Follereau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damien Foundation
City
Anjouan
Country
Comoros
Facility Name
Damien Foundation
City
Mohéli
Country
Comoros
Facility Name
Fondation Raoul Follereau
City
Miandrivazo
State/Province
Menabe
Country
Madagascar

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31805862
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.
Results Reference
derived

Learn more about this trial

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

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