New methods for diagnosing and preventing leprosy
Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh
This study is testing new ways to find and prevent leprosy in people who have been close to someone diagnosed with it, using a single-dose antibiotic and a new test to spot the disease early.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Nilphamari) |
| Trial ID | NCT06222372 on ClinicalTrials.gov |
What this trial studies
This study focuses on identifying asymptomatically infected individuals with Mycobacterium leprae to prevent the transmission of leprosy. It evaluates the effectiveness of post-exposure prophylaxis using single-dose rifampicin (SDR) in contacts of newly diagnosed leprosy patients. The study also employs a novel lateral flow assay to assess immune responses specific to leprosy, aiming to improve early detection and treatment strategies. By integrating these methods into routine leprosy control programs, the study seeks to enhance public health outcomes in endemic regions.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed multibacillary leprosy patients and their close contacts living in the same household or community.
Not a fit: Patients with the pure neural form of leprosy or those living too far from diagnosed patients may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of leprosy by enabling early detection and treatment of at-risk individuals.
How similar studies have performed: Previous studies have shown promise in using prophylactic treatments like SDR for leprosy prevention, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nilphamari
- The Leprosy Mission International - Bangladesh — Nilphamari, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Annemieke Geluk, PhD — Academisch Ziekenhuis Leiden (LUMC)
- Study coordinator: Annemieke Geluk, PhD
- Email: ageluk@lumc.nl
- Phone: +31715261974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.