Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar (PEOPLE)
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| ClinicalTrials.gov Identifier: NCT03662022 |
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Recruitment Status :
Recruiting
First Posted : September 7, 2018
Last Update Posted : April 15, 2019
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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
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium
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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 |
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 to a serological screening test (anti-PGL-1)
| 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
Genetics Home Reference related topics:
Leprosy
MedlinePlus related topics:
Mycobacterial Infections
Drug Information available for:
Rifampin
| Arm | Intervention/treatment |
|---|---|
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No Intervention: No PEP
No PEP will be distributed
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Household PEP
PEP will be given to all household contacts of an incident leprosy patient
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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. |
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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.
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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. |
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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)
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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 :
- 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 :
- 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
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
| Contact: Epco Hasker, MD, PhD | +32(0)32470726 | ehasker@itg.be | |
| Contact: Bouke de Jong, MD, PhD | +32(0)32476590 | bdejong@itg.be |
Locations
| 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
| 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 |
| 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 |
| 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 Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Rifampin Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective 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 |