Trial Outcomes & Findings for Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar (NCT NCT03662022)
NCT ID: NCT03662022
Last Updated: 2025-03-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144000 participants
Primary outcome timeframe
45 months
Results posted on
2025-03-04
Participant Flow
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.
Unit of analysis: Villages
Participant milestones
| Measure |
No PEP
No PEP will be distributed
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Year 1 2019
STARTED
|
24185 8
|
23572 8
|
27196 8
|
19174 8
|
|
Year 1 2019
COMPLETED
|
24102 8
|
23456 8
|
27038 8
|
19075 8
|
|
Year 1 2019
NOT COMPLETED
|
83 0
|
116 0
|
158 0
|
99 0
|
|
Year 2 2020
STARTED
|
25588 8
|
25419 8
|
28430 8
|
20910 8
|
|
Year 2 2020
COMPLETED
|
23919 8
|
24202 8
|
27017 8
|
18002 8
|
|
Year 2 2020
NOT COMPLETED
|
1669 0
|
1217 0
|
1413 0
|
2908 0
|
|
Year 3 2021
STARTED
|
24893 8
|
25257 8
|
28175 8
|
19511 8
|
|
Year 3 2021
COMPLETED
|
24686 8
|
24971 8
|
27661 8
|
19009 8
|
|
Year 3 2021
NOT COMPLETED
|
207 0
|
286 0
|
514 0
|
502 0
|
|
Year 4 2022
STARTED
|
25431 8
|
25760 8
|
28468 8
|
20605 8
|
|
Year 4 2022
COMPLETED
|
24412 8
|
24621 8
|
27191 8
|
18765 8
|
|
Year 4 2022
NOT COMPLETED
|
1019 0
|
1139 0
|
1277 0
|
1840 0
|
Reasons for withdrawal
| Measure |
No PEP
No PEP will be distributed
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Year 1 2019
prevalent case
|
83
|
116
|
158
|
99
|
|
Year 2 2020
incident case
|
18
|
18
|
16
|
26
|
|
Year 2 2020
other case
|
18
|
16
|
16
|
24
|
|
Year 2 2020
Lost to Follow-up
|
1633
|
1183
|
1381
|
2858
|
|
Year 3 2021
incident case
|
24
|
27
|
24
|
11
|
|
Year 3 2021
other case
|
4
|
15
|
10
|
14
|
|
Year 3 2021
Lost to Follow-up
|
179
|
244
|
480
|
477
|
|
Year 4 2022
incident case
|
25
|
41
|
28
|
7
|
|
Year 4 2022
other case
|
8
|
19
|
13
|
7
|
|
Year 4 2022
Lost to Follow-up
|
986
|
1079
|
1236
|
1826
|
Baseline Characteristics
number analyzed in row differs from overall due to missing information
Baseline characteristics by cohort
| Measure |
No PEP
n=27494 Participants
No PEP will be distributed
|
Household PEP
n=27519 Participants
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.
|
PEP 100m
n=30709 Participants
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.
|
PEP 100m + Positive for Anti-PGL-I IgM Ab
n=24944 Participants
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.
|
Total
n=110666 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<5 years old
|
4509 Participants
n=4509 Participants • number analyzed in row differs from overall due to missing information
|
4742 Participants
n=4742 Participants • number analyzed in row differs from overall due to missing information
|
5257 Participants
n=5257 Participants • number analyzed in row differs from overall due to missing information
|
4018 Participants
n=4018 Participants • number analyzed in row differs from overall due to missing information
|
18526 Participants
n=18526 Participants • number analyzed in row differs from overall due to missing information
|
|
Age, Customized
=>5 and <15 years old
|
7775 Participants
n=7775 Participants • number analyzed in row differs from overall due to missing information
|
8192 Participants
n=8192 Participants • number analyzed in row differs from overall due to missing information
|
9062 Participants
n=9062 Participants • number analyzed in row differs from overall due to missing information
|
7455 Participants
n=7455 Participants • number analyzed in row differs from overall due to missing information
|
32484 Participants
n=32484 Participants • number analyzed in row differs from overall due to missing information
|
|
Age, Customized
>=15 and <25 years old
|
5483 Participants
n=5483 Participants • number analyzed in row differs from overall due to missing information
|
5300 Participants
n=5300 Participants • number analyzed in row differs from overall due to missing information
|
6233 Participants
n=6233 Participants • number analyzed in row differs from overall due to missing information
|
5001 Participants
n=5001 Participants • number analyzed in row differs from overall due to missing information
|
22017 Participants
n=22017 Participants • number analyzed in row differs from overall due to missing information
|
|
Age, Customized
25 years old and up
|
9722 Participants
n=9722 Participants • number analyzed in row differs from overall due to missing information
|
9283 Participants
n=9283 Participants • number analyzed in row differs from overall due to missing information
|
10156 Participants
n=10156 Participants • number analyzed in row differs from overall due to missing information
|
8464 Participants
n=8464 Participants • number analyzed in row differs from overall due to missing information
|
37625 Participants
n=37625 Participants • number analyzed in row differs from overall due to missing information
|
|
Age, Customized
Missing
|
5 Participants
n=5 Participants • number analyzed in row differs from overall due to missing information
|
2 Participants
n=2 Participants • number analyzed in row differs from overall due to missing information
|
1 Participants
n=1 Participants • number analyzed in row differs from overall due to missing information
|
6 Participants
n=6 Participants • number analyzed in row differs from overall due to missing information
|
14 Participants
n=14 Participants • number analyzed in row differs from overall due to missing information
|
|
Sex: Female, Male
Female
|
13978 Participants
n=27494 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
13804 Participants
n=27518 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
15303 Participants
n=30709 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
12740 Participants
n=24943 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
55825 Participants
n=110664 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
|
Sex: Female, Male
Male
|
13516 Participants
n=27494 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
13714 Participants
n=27518 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
15406 Participants
n=30709 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
12203 Participants
n=24943 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
54839 Participants
n=110664 Participants • For both the second and fourth arm, there was one participant for which sex was missing
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=27494 Participants
|
0 Participants
n=27519 Participants
|
0 Participants
n=30709 Participants
|
0 Participants
n=24944 Participants
|
0 Participants
n=110666 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=27494 Participants
|
0 Participants
n=27519 Participants
|
0 Participants
n=30709 Participants
|
0 Participants
n=24944 Participants
|
0 Participants
n=110666 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
27494 Participants
n=27494 Participants
|
27519 Participants
n=27519 Participants
|
30709 Participants
n=30709 Participants
|
24944 Participants
n=24944 Participants
|
110666 Participants
n=110666 Participants
|
|
Region of Enrollment
Madagascar
|
4753 Participants
n=4753 Participants • numer analyzed in row differs form overall because of missing data.
|
7087 Participants
n=7087 Participants • numer analyzed in row differs form overall because of missing data.
|
5244 Participants
n=5244 Participants • numer analyzed in row differs form overall because of missing data.
|
4074 Participants
n=4074 Participants • numer analyzed in row differs form overall because of missing data.
|
21158 Participants
n=21158 Participants • numer analyzed in row differs form overall because of missing data.
|
|
Region of Enrollment
Comoros
|
22741 Participants
n=22741 Participants • numer analyzed in row differs form overall because of missing data.
|
20432 Participants
n=20432 Participants • numer analyzed in row differs form overall because of missing data.
|
25465 Participants
n=25465 Participants • numer analyzed in row differs form overall because of missing data.
|
20870 Participants
n=20870 Participants • numer analyzed in row differs form overall because of missing data.
|
89508 Participants
n=89508 Participants • numer analyzed in row differs form overall because of missing data.
|
|
BCG scar
absent
|
7886 Participants
n=27494 Participants
|
8632 Participants
n=27519 Participants
|
11897 Participants
n=30709 Participants
|
11027 Participants
n=24944 Participants
|
39442 Participants
n=110666 Participants
|
|
BCG scar
present
|
18796 Participants
n=27494 Participants
|
17960 Participants
n=27519 Participants
|
17919 Participants
n=30709 Participants
|
12585 Participants
n=24944 Participants
|
67260 Participants
n=110666 Participants
|
|
BCG scar
missing
|
812 Participants
n=27494 Participants
|
926 Participants
n=27519 Participants
|
893 Participants
n=30709 Participants
|
1331 Participants
n=24944 Participants
|
3962 Participants
n=110666 Participants
|
|
Prevalent case
|
83 Participants
n=27494 Participants
|
116 Participants
n=27519 Participants
|
158 Participants
n=30709 Participants
|
99 Participants
n=24944 Participants
|
456 Participants
n=110666 Participants
|
|
incident case
|
67 Participants
n=27494 Participants
|
86 Participants
n=27519 Participants
|
68 Participants
n=30709 Participants
|
44 Participants
n=24944 Participants
|
265 Participants
n=110666 Participants
|
|
other case
|
30 Participants
n=27494 Participants
|
50 Participants
n=27519 Participants
|
39 Participants
n=30709 Participants
|
45 Participants
n=24944 Participants
|
164 Participants
n=110666 Participants
|
|
receive PEP but ineligible or were elibile but did not receive PEP
|
0 Participants
n=27494 Participants
|
155 Participants
n=27519 Participants
|
5123 Participants
n=30709 Participants
|
1336 Participants
n=24944 Participants
|
6614 Participants
n=110666 Participants
|
PRIMARY outcome
Timeframe: 45 monthsPopulation: participants examined
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.
Outcome measures
| Measure |
no PEP
n=27494 Participants
no PEP given
|
Household PEP
n=27519 Participants
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.
|
PEP 100m
n=30709 Participants
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.
|
PEP 100m + Positive for Anti-PGL-I IgM Ab
n=24944 Participants
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.
|
|---|---|---|---|---|
|
Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis
|
1.04 number of new cases per 1000 person/year
Interval 0.8 to 1.32
|
1.42 number of new cases per 1000 person/year
Interval 1.13 to 1.75
|
0.98 number of new cases per 1000 person/year
Interval 0.76 to 1.24
|
0.92 number of new cases per 1000 person/year
Interval 0.67 to 1.23
|
Adverse Events
No PEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Household PEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PEP 100m
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PEP 100m + Positive for Anti-PGL-I IgM Ab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place