Actively Recruiting
Novel Interventions and Diagnostic Tests for Leprosy
Led by Annemieke Geluk · Updated on 2025-09-10
1100
Participants Needed
1
Research Sites
353 weeks
Total Duration
On this page
Sponsors
A
Annemieke Geluk
Lead Sponsor
T
The Leprosy Mission Bangladesh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting. The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.
CONDITIONS
Official Title
Novel Interventions and Diagnostic Tests for Leprosy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed multibacillary leprosy patients with bacterial index 1-6
- Contacts of multibacillary leprosy patients who live in the same house, on the same compound, share the same kitchen, or are direct neighbors
- Willing to participate and provide informed consent
You will not qualify if you...
- Patients refusing examination of their contacts
- Patients with pure neural form of leprosy
- Patients residing only temporarily in the study area
- Patients with paucibacillary leprosy
- Contacts diagnosed with leprosy during examination
- Contacts living less than 100 meters from a patient already included
- Contacts who are first or second degree relatives of an included patient
- Contacts refusing informed consent
- Pregnancy
- Current tuberculosis or leprosy treatment
- Contacts younger than 5 years old
- Known liver disease or jaundice
- Contacts residing temporarily in the study area
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Leprosy Mission International - Bangladesh
Nilphamari, Bangladesh, 5300
Actively Recruiting
Research Team
A
Annemieke Geluk, PhD
CONTACT
A
Anouk van Hooij, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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