Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Leprosy Clinical Trial

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Official title:

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662022
• Other study ID #: 1248/18
• Status: Completed
• Phase: Phase 3
• Start date: January 2, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144000
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leprosy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Comoros	Damien Foundation	Anjouan
Comoros	Damien Foundation	Mohéli
Madagascar	Fondation Raoul Follereau	Miandrivazo	Menabe

Sponsors (8)

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

Countries where clinical trial is conducted

Comoros,  Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare effectiveness in curbing transmission of leprosy of three different approaches of post exposure prophylaxis	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.	45 months
Secondary	Assess cost and feasibility of SDDR-PEP under program conditions	Costs will be calculated per person screened, per person treated with SDDR-PEP and per leprosy case averted.	45 months
Secondary	Identify patterns of clustering in transmission of leprosy, allowing better targeting of control measures	We will quantify the degree of clustering as the average proportion of leprosy cases belonging to a same phylogenetic cluster by village. Geographic clustering will also be assessed by calculating risk ratios for being diagnosed with leprosy as a function of geographic distance from incident cases diagnosed earlier in each of the four arms	45 months
Secondary	Monitor rifampicin resistance among leprosy patients	We will quantify prevalence of Rifampicin resistant strains of M. leprae on each of the study islands making use of molecular markers	45 months
Secondary	Estimate incidence and prevalence of smear positive pulmonary tuberculosis in the study villages	During door-to-door surveys for leprosy we will enquire about chronic cough and screen for pulmonary tuberculosis if indicated. Prevalence of pulmonary tuberculosis will be calculated per island based on the results of the baseline survey, using as denominator the total population screened on the island. After each survey round annual incidence rates will be calculated based on the results of the follow-up surveys	45 months