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Novel Interventions and Diagnostic Tests for Leprosy

NCT06222372 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2025-09-10

No results posted yet for this study

Summary

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

  • Leprosy

Interventions

DRUG

Rifampin

antibiotic

Sponsors & Collaborators

  • The Leprosy Mission Bangladesh

    collaborator OTHER

  • Annemieke Geluk

    lead OTHER

Principal Investigators

  • Annemieke Geluk, PhD · Academisch Ziekenhuis Leiden (LUMC)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2026-06-01
Completion
2026-12-15

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06222372 on ClinicalTrials.gov