Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: t
View:

⁃ \- 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

Locations
Other Locations
Bangladesh
The Leprosy Mission International - Bangladesh
RECRUITING
Nilphamari
Contact Information
Primary
Annemieke Geluk, PhD
ageluk@lumc.nl
+31715261974
Backup
Anouk van Hooij, PhD
A.van_Hooij@lumc.nl
+31715263844
Time Frame
Start Date: 2020-03-04
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 1100
Treatments
Experimental: Single dose rifampin (SDR)
To household contacts of newly diagnosed leprosy patients SDR is provided as follows: 600 mg rifampicin for adults weighing 35 kg and over, 450 mg for adults weighing less than 35 kg and for children older than 9 years, and 300 mg for children aged 5 to 9 years.
Experimental: Single double dose rifampin (SDDR)
To household contacts of newly diagnosed leprosy patients SDDR is provided as follows: 1200 mg rifampicin for adults weighing 35 kg and over, 900 mg for adults weighing less than 35 kg and for children older than 9 years, and 600 mg for children aged 5 to 9 years.
Related Therapeutic Areas
Sponsors
Collaborators: The Leprosy Mission Bangladesh
Leads: Annemieke Geluk

This content was sourced from clinicaltrials.gov