Novel Interventions and Diagnostic Tests for Leprosy (NCT06222372) | Clinical Trial Compass
RecruitingNot Applicable
Novel Interventions and Diagnostic Tests for Leprosy
Bangladesh1,100 participantsStarted 2020-03-04
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of levels of host serum proteins in contacts after SDR
Timeframe: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR
2
Changes of levels of host serum proteins in contacts after SDDR
Timeframe: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR