CompletedNCT03662022PEOPLEUpdated Mar 4, 2025Results posted

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

A Phase 3 interventional study of Rifampicin in Leprosy, sponsored by Institute of Tropical Medicine, Belgium. Completed at 3 sites in 2 countries. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Institute of Tropical Medicine, Belgium · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 144,000
Allocation: Randomized
Ages: 2 Years and older
Sex: All

Study 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.

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 studied

Leprosy

Browse trials for

Leprosy 51

Who can participate

Ages eligible: 2 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Living in one of the study villages
Aged 2 years and above
Able and willing to provide informed consent

Exclusion criteria

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 design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 144,000 participants (actual)

Study arms

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
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.
Drug: Rifampicin
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)
Drug: Rifampicin

Interventions

DrugRifampicin
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 researchers measure

Primary outcomes

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.
Time frame: 45 months

Results

Posted Mar 4, 2025

Participant flow

Year 1 2019

Participant flow — Year 1 2019
Milestone	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab
Started	24185	23572	27196	19174
Completed	24102	23456	27038	19075
Not completed	83	116	158	99
Withdrew: Prevalent case	83	116	158	99

Year 2 2020

Participant flow — Year 2 2020
Milestone	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab
Started	25588	25419	28430	20910
Completed	23919	24202	27017	18002
Not completed	1669	1217	1413	2908
Withdrew: Incident case	18	18	16	26
Withdrew: Other case	18	16	16	24
Withdrew: Lost to follow-up	1633	1183	1381	2858

Year 3 2021

Participant flow — Year 3 2021
Milestone	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab
Started	24893	25257	28175	19511
Completed	24686	24971	27661	19009
Not completed	207	286	514	502
Withdrew: Incident case	24	27	24	11
Withdrew: Other case	4	15	10	14
Withdrew: Lost to follow-up	179	244	480	477

Year 4 2022

Participant flow — Year 4 2022
Milestone	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab
Started	25431	25760	28468	20605
Completed	24412	24621	27191	18765
Not completed	1019	1139	1277	1840
Withdrew: Incident case	25	41	28	7
Withdrew: Other case	8	19	13	7
Withdrew: Lost to follow-up	986	1079	1236	1826

Outcome measures

PrimaryCompare 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.

Time frame:: 45 months
Reported as:: Number · number of new cases per 1000 person/year

Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis
number of new cases per 1000 person/year	no PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab
Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis	1.04 (0.8 to 1.32)	1.42 (1.13 to 1.75)	0.98 (0.76 to 1.24)	0.92 (0.67 to 1.23)

Statistical analysis

no PEP vs Household PEP · Mixed Models Analysis · p = <0.017 (The significance level was determined at 0.017, to account for the fact that we made three comparisons, thus conclusions can be drawn by examining if the 98.3% CI for the incidence rate ratio (IRR) contains the critical value of 1.) · Incidence rate ratio: 0.95 · 98.3% CI 0.40 to 2.23
no PEP vs PEP 100m · Mixed Models Analysis · p = 0.017 · Incidence rate ratio: 0.80 · 98.3% CI 0.34 to 1.87
no PEP vs PEP 100m + Positive for Anti-PGL-I IgM Ab · Mixed Models Analysis · p = <0.017 · Incidence rate ratio: 0.58 · 98.3% CI 0.22 to 1.56

Adverse events

Collected over 1 day (during PEP administration visit) per year. Throughout the study (4 years) passive reporting was possible.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
No PEP	—	—	—
Household PEP	0/731 (0%)	0/731 (0%)	0/731 (0%)
PEP 100m	0/15,203 (0%)	0/15,203 (0%)	0/15,203 (0%)
PEP 100m + Positive for Anti-PGL-I IgM Ab	0/2,850 (0%)	0/2,850 (0%)	0/2,850 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
<5 years old	4509	4742	5257	4018	18526
=>5 and <15 years old	7775	8192	9062	7455	32484
>=15 and <25 years old	5483	5300	6233	5001	22017
25 years old and up	9722	9283	10156	8464	37625
Missing	5	2	1	6	14

Sex: Female, Male
Sex: Female, Male(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
Female	13978	13804	15303	12740	55825
Male	13516	13714	15406	12203	54839

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	0	0	0	0	0
Unknown or Not Reported	27494	27519	30709	24944	110666

Region of Enrollment
Region of Enrollment(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
Madagascar	4753	7087	5244	4074	21158
Comoros	22741	20432	25465	20870	89508

BCG scar
BCG scar(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
absent	7886	8632	11897	11027	39442
present	18796	17960	17919	12585	67260
missing	812	926	893	1331	3962

Prevalent case
Prevalent case(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
Count of participants	83	116	158	99	456

incident case
incident case(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
Count of participants	67	86	68	44	265

other case
other case(Participants)	No PEP	Household PEP	PEP 100m	PEP 100m + Positive for Anti-PGL-I IgM Ab	Total
Count of participants	30	50	39	45	164

1 further baseline measures are reported on the registry.

Study locations

3 sites

Damien Foundation
Anjouan, Comoros
Damien Foundation
Mohéli, Comoros
Fondation Raoul Follereau
Miandrivazo, Menabe, Madagascar

References and documents

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. PubMed 31805862 ↗

Study documents

Study protocol · Mar 18, 2022
Statistical analysis plan · Sep 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

Registry details

Key details

Study ID: NCT03662022
Lead 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
Responsible party: Sponsor
First posted: Sep 7, 2018
Start date: Jan 2, 2019
Primary completion: Jan 17, 2023
Completion: Jan 17, 2023
Results posted: Mar 4, 2025
Last update: Mar 4, 2025

Study contacts

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

Bertrand Cauchoix, MD

principal investigator · Fondation Raoul Follereau

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leprosy→

Other studies from this sponsor

Institute of Tropical Medicine, Belgium

Start the discussion