Novel Interventions and Diagnostic Tests for Leprosy
Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh
Annemieke Geluk
1,100 participants
Mar 4, 2020
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria7
- \- newly diagnosed multibacillary leprosy patients (BI 1-6)
- living in the same house (household members)
- living in a house on the same compound
- sharing the same kitchen
- direct neighbors (first neighbors)
- willing to participate
- provide informed consent
Exclusion Criteria13
- refusal of examination of their contacts
- suffering from the pure neural form of leprosy
- residing only temporarily in the study area
- PB leprosy patients
- diagnosed as leprosy patients during contact examination
- living less than 100 m away from a patient already included in the study
- first and second degree relatives of a patient already included in the study
- refusal informed consent
- pregnancy
- tuberculosis or leprosy treatment
- below 5 years of age
- known to suffer from liver disease or jaundice
- residing temporarily in the study area
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Interventions
antibiotic
Locations(1)
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NCT06222372