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Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03662022
Acronym
PEOPLE
Enrollment
144000
Registered
2018-09-07
Start date
2019-01-02
Completion date
2023-01-17
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leprosy

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.

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 in the UCP-LFA detecting anti-M. leprae PGL-I IgM antibodies (Ab) in fingerstick blood (anti-PGL-1)

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.

Sponsors

Damien Foundation
CollaboratorOTHER
Centre d'Infectiologie Charles Mérieux
CollaboratorOTHER
Fondation Raoul Follereau
CollaboratorUNKNOWN
Leiden University Medical Center
CollaboratorOTHER
L'Institut National de la Santé et de la Recherche Médicale
CollaboratorUNKNOWN
Genoscreen
CollaboratorOTHER
Instituto Fernandes Figueira
CollaboratorOTHER_GOV
Institute of Tropical Medicine, Belgium
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A cluster randomized trial in which villages are assigned to one of four intervention groups

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis45 monthsleprosy 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.

Countries

Comoros, Madagascar

Participant flow

Pre-assignment details

Some participants will not have been present during the door to door screening of each year. It is possible that some pts will only have been screened in a limited number of periods. This explains the discrepancy between the enrollment nr in the protocol section and the pts assigned to the arms in period 1 (and other periods).Please note that the pts counts in the 'baseline characteristics' are the total of all started pts (in all years). This number reflects the total number analyzed.

Participants by arm

ArmCount
No PEP
No PEP will be distributed
27,494
Household PEP
PEP will be given to all household contacts of an incident leprosy patient 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.
27,519
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: 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.
30,709
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: 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.
24,944
Total110,666

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Year 1 2019prevalent case8311615899
Year 2 2020incident case18181626
Year 2 2020Lost to Follow-up1,6331,1831,3812,858
Year 2 2020other case18161624
Year 3 2021incident case24272411
Year 3 2021Lost to Follow-up179244480477
Year 3 2021other case4151014
Year 4 2022incident case2541287
Year 4 2022Lost to Follow-up9861,0791,2361,826
Year 4 2022other case819137

Baseline characteristics

CharacteristicTotalPEP 100m + Positive for Anti-PGL-I IgM AbPEP 100mHousehold PEPNo PEP
Age, Customized
>=15 and <25 years old
22017 Participants5001 Participants6233 Participants5300 Participants5483 Participants
Age, Customized
25 years old and up
37625 Participants8464 Participants10156 Participants9283 Participants9722 Participants
Age, Customized
=>5 and <15 years old
32484 Participants7455 Participants9062 Participants8192 Participants7775 Participants
Age, Customized
<5 years old
18526 Participants4018 Participants5257 Participants4742 Participants4509 Participants
Age, Customized
Missing
14 Participants6 Participants1 Participants2 Participants5 Participants
BCG scar
absent
39442 Participants11027 Participants11897 Participants8632 Participants7886 Participants
BCG scar
missing
3962 Participants1331 Participants893 Participants926 Participants812 Participants
BCG scar
present
67260 Participants12585 Participants17919 Participants17960 Participants18796 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
110666 Participants24944 Participants30709 Participants27519 Participants27494 Participants
incident case265 Participants44 Participants68 Participants86 Participants67 Participants
other case164 Participants45 Participants39 Participants50 Participants30 Participants
Prevalent case456 Participants99 Participants158 Participants116 Participants83 Participants
receive PEP but ineligible or were elibile but did not receive PEP6614 Participants1336 Participants5123 Participants155 Participants0 Participants
Region of Enrollment
Comoros
89508 Participants20870 Participants25465 Participants20432 Participants22741 Participants
Region of Enrollment
Madagascar
21158 Participants4074 Participants5244 Participants7087 Participants4753 Participants
Sex: Female, Male
Female
55825 Participants12740 Participants15303 Participants13804 Participants13978 Participants
Sex: Female, Male
Male
54839 Participants12203 Participants15406 Participants13714 Participants13516 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 7310 / 15,2030 / 2,850
other
Total, other adverse events
0 / 00 / 7310 / 15,2030 / 2,850
serious
Total, serious adverse events
0 / 00 / 7310 / 15,2030 / 2,850

Outcome results

Primary

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

Population: participants examined

ArmMeasureValue (NUMBER)
no PEPCompare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis1.04 number of new cases per 1000 person/year
Household PEPCompare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis1.42 number of new cases per 1000 person/year
PEP 100mCompare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis0.98 number of new cases per 1000 person/year
PEP 100m + Positive for Anti-PGL-I IgM AbCompare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis0.92 number of new cases per 1000 person/year
p-value: <0.01798.3% CI: [0.4, 2.23]Mixed Models Analysis
p-value: 0.01798.3% CI: [0.34, 1.87]Mixed Models Analysis
p-value: <0.01798.3% CI: [0.22, 1.56]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026