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| Name | Class |
|---|---|
| Damien Foundation | OTHER |
| Centre d'Infectiologie Charles Mérieux | OTHER |
| Fondation Raoul Follereau | UNKNOWN |
| Leiden University Medical Center |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 months |
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Inclusion Criteria:
Exclusion Criteria:
(*) These people may still be included for yearly leprosy screening, but will be excluded to receive PEP
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| Name | Affiliation | Role |
|---|---|---|
| Bouke de Jong, MD, PhD | Institute of Tropical Medicine | Study Chair |
| Epco Hasker, MD | Institute of Tropical Medicine | Study Director |
| Younoussa Assoumani, MD | Damien Foundation | Principal Investigator |
| Bertrand Cauchoix, MD | Fondation Raoul Follereau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damien Foundation | Anjouan | Comoros | ||||
| Damien Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38762282 | Derived | 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. | |
| 35850123 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | No PEP | No PEP will be distributed |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 2019 |
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| Year 2 2020 |
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| Year 3 2021 |
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| Year 4 2022 |
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| ID | Title | Description |
|---|---|---|
| BG000 | No PEP | No PEP will be distributed |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | number analyzed in row differs from overall due to missing information |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | participants examined | Posted | Number | 95% Confidence Interval | number of new cases per 1000 person/year | 45 months |
|
1 day (during PEP administration visit) per year. Throughout the study (4 years) passive reporting was possible.
There have been no adverse Events reported until now. Participants have been invited to report any adverse events to the study teams while they are present in the villages, the median duration the teams were present in a village in 2022 for example was 20 days. However no such events have been reported.
For the no PEP arm, no adverse events were monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No PEP | No PEP will be distributed | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolien Hoof | Insitute of Tropical Medicine | +32470102562 | choof@itg.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2022 | Aug 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2020 | Aug 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007918 | Leprosy |
| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| L'Institut National de la Santé et de la Recherche Médicale | UNKNOWN |
| Genoscreen | OTHER |
| Instituto Fernandes Figueira | OTHER_GOV |
A cluster randomized trial in which villages are assigned to one of four intervention groups
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| Mohéli |
| Comoros |
| Fondation Raoul Follereau | Miandrivazo | Menabe Region | Madagascar |
| Derived |
| Marijke 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. |
| 31805862 | Derived | 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. |
| COMPLETED | participants under follow up |
|
| NOT COMPLETED |
|
|
| COMPLETED | participants under follow up |
|
| NOT COMPLETED |
|
|
| COMPLETED | participants under follow up |
|
| NOT COMPLETED |
|
|
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | For both the second and fourth arm, there was one participant for which sex was missing | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | numer analyzed in row differs form overall because of missing data. | Count of Participants | Participants |
|
| BCG scar | Count of Participants | Participants |
|
| Prevalent case | Count of Participants | Participants |
|
| incident case | Count of Participants | Participants |
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| other case | Count of Participants | Participants |
|
| receive PEP but ineligible or were elibile but did not receive PEP | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 731 | 0 | 731 | 0 | 731 |
| EG002 | 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. | 0 | 15,203 | 0 | 15,203 | 0 | 15,203 |
| EG003 | 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. | 0 | 2,850 | 0 | 2,850 | 0 | 2,850 |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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