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Novel Interventions and Diagnostic Tests for Leprosy

RecruitingNAAges 5 Years - anyAllAnnemieke Geluk
NCT06222372 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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), pro

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📋 Eligibility rules (as published)
Inclusion Criteria patients: \- newly diagnosed multibacillary leprosy patients (BI 1-6) Inclusion Criteria contacts of MB leprosy patients: * 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 Criteria patients: * refusal of examination of their contacts * suffering from the pure neural form of leprosy * residing only temporarily in the study area * PB leprosy patients Exclusion Criteria contacts: * 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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What it tests

  • Rifampin
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Where

1 site
The Leprosy Mission International - Bangladesh
Nilphamari, Bangladesh
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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