Novel Interventions and Diagnostic Tests for Leprosy
ConditionLeprosy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorAnnemieke Geluk
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
living in the same house (household members)
living in a house on the same compound
sharing the same kitchen
direct neighbors (first neighbors)
Disqualifiers
refusal of examination of their contacts
suffering from the pure neural form of leprosy
residing only temporarily in the study area
PB leprosy patients
Trial design
Design model
Parallel
Treatments tested in this trial
Rifampin
Drugantibiotic
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Single dose rifampin (SDR)Experimental treatment 1 intervention
Group B: Single double dose rifampin (SDDR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of levels of host serum proteins in contacts after SDR
Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples
Time frame
samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR2
Changes of levels of host serum proteins in contacts after SDDR
Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples
Time frame
samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDRSecondary outcomes
1
Changes in bacterial load in contacts after SDR
determining M.leprae DNA in nasal swabs
Time frame
samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR2
Changes in bacterial load in contacts after SDDR
determining M.leprae DNA in nasal swabs
Time frame
samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Annemieke Geluk
Lead sponsor
Leiden University Medical Center
Sponsor institution
The Leprosy Mission Bangladesh
Collaborator
Source ClinicalTrials.gov