New methods for diagnosing and preventing leprosy
Official title: Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh
Run by Leiden University Medical Center · NCT06222372 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Nilphamari) |
| Status | Recruiting |
| Started | March 4, 2020 |
| Main results expected | June 1, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT06222372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include newly diagnosed multibacillary leprosy patients and their close contacts living in the same household or community.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using prophylactic treatments like SDR for leprosy prevention, indicating a potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ultrasound-guided ulnar nerve PCR test to diagnose and monitor leprosy
This test uses an ultrasound-guided needle sample from the ulnar nerve combined with PCR to see if it can detect Mycobacterium leprae and help diagnose or monitor people with suspected or confirmed leprosy.
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Exploring Rab 32 Gene Variations in Leprosy Patients
This study is trying to see if differences in a specific gene can help predict how leprosy patients will respond to treatment and how severe their disease might be.
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Bedaquiline for preventing leprosy after exposure
This study is testing if a new treatment called Bedaquiline can better prevent leprosy in people living close to someone who has the disease compared to the usual medication.
-
Using metformin to improve treatment for multibacillary leprosy
This study is testing if adding metformin to the standard treatment for newly diagnosed multibacillary leprosy can help reduce complications and improve safety for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.