- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662022
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar (PEOPLE)
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
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)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Anjouan, Comoros
- Damien Foundation
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Mohéli, Comoros
- Damien Foundation
-
-
-
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Menabe
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Miandrivazo, Menabe, Madagascar
- Fondation Raoul Follereau
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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45 months
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Monitor rifampicin resistance among leprosy patients
Time Frame: 45 months
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We will quantify prevalence of Rifampicin resistant strains of M. leprae on each of the study islands making use of molecular markers
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45 months
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Estimate incidence and prevalence of smear positive pulmonary tuberculosis in the study villages
Time Frame: 45 months
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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
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45 months
|
Collaborators and Investigators
Collaborators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Mycobacterium Infections, Nontuberculous
- Leprosy
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Rifampin
Other Study ID Numbers
- 1248/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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