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Trial record 7 of 14 for:    "Hansen's Disease" | "Anti-Infective Agents"

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 : April 15, 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

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.


Condition or disease Intervention/treatment Phase
Leprosy Drug: Rifampicin Phase 3

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 to a serological screening test (anti-PGL-1)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144000 participants
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
Official Title: Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
No Intervention: No PEP
No PEP will be distributed
Household PEP
PEP will be given to all household contacts of an incident leprosy patient
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.

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.
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.

PEP 100m + positive anti-PGL-1
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 for a serological screening test (anti-PGL-1)
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662022


Contacts
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Contact: Epco Hasker, MD, PhD +32(0)32470726 ehasker@itg.be
Contact: Bouke de Jong, MD, PhD +32(0)32476590 bdejong@itg.be

Locations
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Comoros
Damien Foundation Recruiting
Anjouan, Comoros
Contact: Younoussa Assoumani, MD    +2693326308    yaoussoumani@gmail.com   
Principal Investigator: Younoussa Assoumani, MD         
Damien Foundation Recruiting
Mohéli, Comoros
Contact: Younoussa Assoumani, MD    +2693326308    yaoussoumani@gmail.com   
Principal Investigator: Younoussa Assoumani, MD         
Madagascar
Fondation Raoul Follereau Not yet recruiting
Miandrivazo, Menabe, Madagascar
Contact: Bertrand Cauchoix, MD       cauchoixbertrand4@gmail.com   
Principal Investigator: Bertrand Cauchoix, MD         
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
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
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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

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT03662022     History of Changes
Other Study ID Numbers: 1248/18
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leprosy
Anti-Infective Agents
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers