LeprosyPhase 3PEOPLENCT03662022
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
A Phase 3 study testing Rifampicin in people with Leprosy, run by Institute of Tropical Medicine, Belgium at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Jan 2019to 17 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Living in one of the study villages
- Aged 2 years and above
- Able and willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Comoros2 sites
Damien Foundation
Anjouan
Damien Foundation
Mohéli
About this study
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.
Read the 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)
- Conditions
- Leprosy
- Being tested
- Rifampicin
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
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 group | Role | What they receive |
|---|---|---|
| No PEP | No intervention | No PEP will be distributed |
| Household PEP | Other | PEP will be given to all household contacts of an incident leprosy patient Receives: Drug: Rifampicin |
| PEP 100m | Experimental | 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. Receives: Drug: Rifampicin |
| PEP 100m + positive for anti-PGL-I IgM Ab | Other | 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) Receives: Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis
leprosy number of new cases per 1000 person years is reported. Incident cases were cases newly diagnosed while under follow-up.
In the statisical analysis table: 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.
Please note that accross the years a part of the same participants are revisited again, which might explain discrepancies in the overall number of participants analyzed.
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start2 Jan 2019
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized trial in which villages are assigned to one of four intervention groups
- Masking
- None (open label)
- Enrolment
- 144,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Bouke de Jong, MD, PhD, Study chair, Institute of Tropical MedicineEpco Hasker, MD, Study director, Institute of Tropical MedicineYounoussa Assoumani, MD, Principal investigator, Damien FoundationBertrand Cauchoix, MD, Principal investigator, Fondation Raoul Follereau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662022
- Sponsor's protocol ID
- 1248/18
- Acronym
- PEOPLE
- Status last verified
- Feb 2025
- First submitted
- 5 Sep 2018
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hasker E, Assoumani Y, Randrianantoandro A, Ramboarina S, Braet SM, Cauchoix B, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Attoumani N, Grillone SH, Ronse M, Peeters Grietens K, Rakoto-Andrianarivelo M, Harinjatovo H, Supply P, Snijders R, Hoof C, Tsoumanis A, Suffys P, Rasamoelina T, Corstjens P, Ortuno-Gutierrez N, Geluk A, Cambau E, de Jong BC. Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial. Lancet Glob Health. 2024 Jun;12(6):e1017-e1026. doi: 10.1016/S2214-109X(24)00062-7.
PubMed 38762282Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.
PubMed 35850123Ortuno-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.
PubMed 31805862
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
- ClinicalTrials.gov ID
- NCT03662022
- Acronym / sponsor ID
- PEOPLE / 1248/18
- Conditions
- Leprosy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144,000 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- 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
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A cluster randomized trial in which villages are assigned to one of four intervention groups
| Arm | Type | Receives |
|---|---|---|
| No PEP | No intervention | –No PEP will be distributed |
| Household PEP | Other | Drug: RifampicinPEP will be given to all household contacts of an incident leprosy patient |
| PEP 100m | Experimental | Drug: RifampicinPEP 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 100m + positive for anti-PGL-I IgM Ab | Other | Drug: RifampicinPEP 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) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Living in one of the study villages
- Aged 2 years and above
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifampicinRifampicin 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. | Drug | Household PEP, PEP 100m, PEP 100m + positive for anti-PGL-I IgM Ab |
Primary outcome
Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis
Time frame: 45 months
leprosy number of new cases per 1000 person years is reported. Incident cases were cases newly diagnosed while under follow-up. In the statisical analysis table: 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. Please note that accross the years a part of the same participants are revisited again, which might explain discrepancies in the overall number of participants analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38762282Hasker E, Assoumani Y, Randrianantoandro A, Ramboarina S, Braet SM, Cauchoix B, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Attoumani N, Grillone SH, Ronse M, Peeters Grietens K, Rakoto-Andrianarivelo M, Harinjatovo H, Supply P, Snijders R, Hoof C, Tsoumanis A, Suffys P, Rasamoelina T, Corstjens P, Ortuno-Gutierrez N, Geluk A, Cambau E, de Jong BC. Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial. Lancet Glob Health. 2024 Jun;12(6):e1017-e1026. doi: 10.1016/S2214-109X(24)00062-7.
- Derived from this study: PubMed 35850123Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.
- Derived from this study: PubMed 31805862Ortuno-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouke de Jong, MD, PhD study chair
Institute of Tropical Medicine
Epco Hasker, MD study director
Institute of Tropical Medicine
Younoussa Assoumani, MD principal investigator
Damien Foundation
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifampicin in people with Leprosy, run by Institute of Tropical Medicine, Belgium at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Comoros, Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis (time frame: 45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662022, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.