An interventional study of Rifampin in Leprosy, sponsored by Annemieke Geluk. Recruiting at 1 site in Bangladesh. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Annemieke Geluk · Not applicable, Interventional, and Prevention
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.
A stable leprosy new case detection rate in many endemic countries indicates that the transmission of M. leprae is continuing unabated and that the current control strategy of case finding and provision of multi drug therapy (MDT) is not sufficient. Immunoprophylaxis by vaccination or post-exposure prophylaxis (PEP) with antibiotics provide effective strategies for the prevention of leprosy. Prophylactic treatment with single dose rifampicin (SDR) has shown to be a successful method to prevent leprosy in contacts of newly diagnosed leprosy patients (1). Currently, the Leprosy Post-Exposure Prophylaxis (LPEP) program generates evidence on the feasibility of integrating contact tracing and single-dose rifampicin (SDR) administration into routine leprosy control activities within the national leprosy control programmes of Brazil, Cambodia, India, Indonesia, Myanmar, Nepal, Sri Lanka and Tanzania [Steinmann P, et al]. Recently, the world health orginazation (WHO) has endorsed PEP for routine application in their new "Guidelines for the diagnosis, treatment and prevention of leprosy".
Genomic and transcriptomics analysis (e.g. population- and twin studies [5]), have determined that the host genetic background is an important risk factor for leprosy susceptibility. In addition, close contacts of leprosy patients have a higher risk of developing the disease (2, 3), which therefore represents the primary target group for interventions (4). To target individuals spreading leprosy bacilli for prophylactic treatment, M. leprae infection needs to be measurable objectively. Antibody levels correspond with bacterial load and risk of transmission. Also, individuals seropositive for anti-M. leprae phenolic glycolipid-I (PGL-I) antibodies, are at 5-8 fold higher risk of leprosy (5, 6). Moreover, in a leprosy endemic area in Bangladesh, we recently showed significant added value of cellular markers (cytokines, chemokines, acute phase proteins) to identify infection (7). Thus, for implementation in a PEP-approach, new tests that indicate who needs treatment should allow detection of both cellular-and humoral markers.
In previous studies applying UCP-LFA in 4 countries with variable leprosy endemicity (Bangladesh, Brazil, China and Ethiopia), we have shown that the combined assessment of serum levels of multiple biomarkers including anti-PGL-I Ab as well as cytokines, significantly improved the diagnostic potential for detection of M. leprae infected individuals. This demonstrates that UCP-LFAs for detection of multiple biomarkers can provide valuable tools for more accurate detection of M. leprae infection. Its low-complexity POC format and applicability for use of finger-stick blood allows large scale screening efforts in field settings. Moreover, the format of the UCP-LFA is being further developed in various other projects (focused on tuberculosis and leprosy diagnostic tests). This has recently resulted in a multi-biomarker test (MBT) format that allows simultaneous detection of up to 6 markers, which is currently further evaluated in the field for tuberculosis diagnostic purposes. Since the UCP-LFA format is flexible and can accommodate for detection of different markers, this latest development will also enable combined detection of humoral and cellular biomarkers which together represent a specific signature for M. leprae infection.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →This is the only study on the registry with Annemieke Geluk as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria patients:
- newly diagnosed multibacillary leprosy patients (BI 1-6)
Inclusion Criteria contacts of MB leprosy patients:
Exclusion Criteria patients:
Exclusion Criteria contacts:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Rifampin
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.
Drug: Rifampin
antibiotic
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 SDR
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 SDDR
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 SDR
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 SDDR
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2020 (actual). Primary completion is estimated for Jun 2026, 74 months after the start.
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Studies of the drug tested here: Rifampin