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

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ClinicalTrials.gov Identifier: NCT03662022
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 18, 2019
Sponsor:
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
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Official Title  ICMJE Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
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:

  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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A cluster randomized trial in which villages are assigned to one of four intervention groups
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Leprosy
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE
  • No Intervention: No PEP
    No PEP will be distributed
  • Household PEP
    PEP will be given to all household contacts of an incident leprosy patient
    Intervention: Drug: Rifampicin
  • 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.
    Intervention: Drug: Rifampicin
  • 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)
    Intervention: Drug: Rifampicin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
144000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Epco Hasker, MD, PhD +32(0)32470726 ehasker@itg.be
Contact: Bouke de Jong, MD, PhD +32(0)32476590 bdejong@itg.be
Listed Location Countries  ICMJE Comoros,   Madagascar
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662022
Other Study ID Numbers  ICMJE 1248/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Institute of Tropical Medicine, Belgium
Study Sponsor  ICMJE Institute of Tropical Medicine, Belgium
Collaborators  ICMJE
  • 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
Investigators  ICMJE
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
PRS Account Institute of Tropical Medicine, Belgium
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP