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Search / Trial NCT06222372

Novel Interventions and Diagnostic Tests for Leprosy

Launched by ANNEMIEKE GELUK · Jan 15, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Leprosy, Diagnostics, Sdr, Post Exposure Prophylaxis (Pep), Biomarkers, Ucp Lfa

ClinConnect Summary

This clinical trial is studying new ways to detect and prevent leprosy, a disease caused by the bacteria Mycobacterium leprae. The focus is on finding individuals who might be infected but do not yet show symptoms. By identifying these people early, health workers can provide treatment to stop the spread of leprosy. The study will use a test called UCP-LFA, which helps determine if someone is infected with the bacteria before and after giving a preventive treatment called single dose rifampin (SDR).

To participate in this trial, you need to be a household contact of a newly diagnosed leprosy patient or be one of those patients yourself. Eligible participants should be living in the same household or compound, sharing a kitchen, or being direct neighbors. The study is open to individuals aged 18 and older, regardless of gender. Participants can expect to undergo some tests and receive health education about leprosy during the study. It's important to know that anyone currently being treated for leprosy or tuberculosis, pregnant women, and young children (under 5 years old) are not eligible to join.

Gender

ALL

Eligibility criteria

  • 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

About Annemieke Geluk

Annemieke Geluk is a dedicated clinical trial sponsor with a focus on advancing medical research and improving patient outcomes. With a robust portfolio of innovative studies, she emphasizes collaboration and ethical practices in the development of new therapies. Annemieke's commitment to scientific excellence is reflected in her strategic partnerships with leading research institutions and healthcare professionals, ensuring that trials are designed and executed with the highest standards of quality and integrity. Her leadership fosters an environment of transparency and accountability, ultimately aiming to bring transformative solutions to patients in need.

Locations

Nilphamari, , Bangladesh

Patients applied

0 patients applied

Trial Officials

Annemieke Geluk, PhD

Principal Investigator

Academisch Ziekenhuis Leiden (LUMC)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported