LAMP Assay for the Diagnosis of Visceral Leishmaniasis (EvaLAMP)
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|ClinicalTrials.gov Identifier: NCT04003532|
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : August 10, 2020
|Condition or disease|
Leishmaniasis is among the World's important neglected infectious diseases (NIDs). The WHO estimates that 350 million people are at risk of contracting leishmaniasis. Visceral leishmaniasis (VL) is the most severe form of the disease. Ethiopia has been recently listed by WHO among the fourteen countries in the world with the highest burden of VL. The development of novel point-of-care (PoC) diagnostics and/or a Test-of-Cure (ToC) for VL is deemed a key priority research area. In several endemic areas current gold standard diagnosis and monitoring of treatment efficacy of VL is based on parasite detection or serology. However, these tests are either not available for routine use or lack sufficient sensitivity and specificity, in particular in HIV co-infected patients. Though molecular tests such as PCR have become popular choices as a tool to diagnose VL, monitor treatment response and predict relapse, these techniques require technical skill and equipment and are considerably more expensive. Recent advances in diagnostics has been the development of LAMP with several advantages, such as no need for thermocycler, high specificity, simple read-out and no cold chain requirements. Therefore, LAMP has emerged as a powerful tool for PoC diagnostics. Its clinical utility as PoC diagnosis and/or ToC for VL in the African setting is, however, hardly known.
Here, the investigators will evaluate the utility of the LAMP as a PoC and/or ToC for VL in an endemic area in Ethiopia. The performance of the LAMP assay as a diagnostic tool will be evaluated in newly diagnosed VL cases confirmed by parasite detection and/or PCR. Furthermore, the use of the assay as ToC will be determined by evaluating the performance of the assay in VL patients confirmed cured at day 17 of therapy, as assessed by negative parasite and/or PCR results. Additionally, the investigators plan to utilize a newly developed rapid molecular platform, db-PCR-NALFIA, which does not require DNA extraction, has an internal amplification control and simple read-out. The investigators will evaluate the utility of both assays also in patients co-infected with HIV. The results may have major policy implications as the application represents a concept that could enhance evidence- based translation of research to improve public health practice by contributing to leishmaniasis management guidelines - with overarching impacts for National, Regional and Global programs.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Evaluation of the Loop-mediated Amplification Assay and Direct-Blood PCR-Nucleic-Acid Lateral Flow Immuno-Assay for the Diagnosis and/or as Test-of-Cure in Patients With Visceral Leishmaniasis in Ethiopia|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2023|
- Number of participants correctly diagnosed with VL as assessed by LAMP assay [ Time Frame: Baseline ]Performance of the LAMP will be compared to gold- standard diagnostic procedures, including parasite detection and/or PCR-technology
- Number of participants treated for VL and identified as cured (ToC) at day 17 post-treatment based on the assessment by LAMP assay [ Time Frame: Baseline ]LAMP will be compared to gold- standard diagnostic procedures, including parasite detection and/or PCR-technology
- Number of participants co-infected with HIV correctly diagnosed with VL as well as treated participants identified as cured (ToC) at day 17 based on the assessment by LAMP assay [ Time Frame: 17 days ]LAMP will be compared to gold-standard diagnostic procedures, including parasite detection and/or PCR-technology
- Number of participants correctly diagnosed as VL based on db-PCR-NALFIA technology [ Time Frame: Baseline ]The investigators will develop db-PCR-NALFIA technology for the diagnosis of VL, i.e. sample preparation and result read-out will be adopted using db-PCR-NALFIA technology as PoC platform. It's performance will be evaluated against gold-standard.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003532
|Contact: Dawit Wolday, MD, PhDfirstname.lastname@example.org|
|Contact: Yazezew Kebede, MDemail@example.com|
|Mekelle University College of Health Sciences||Recruiting|
|Contact: Dawit Wolday, MD, PhD +251911208984 firstname.lastname@example.org|
|Contact: Yazezew Kebede, MD +251910104422 email@example.com|
|Principal Investigator: Dawit Wolday, MD, PhD|
|Sub-Investigator: Yazezew Kebede, MD|
|Sub-Investigator: Mahmoud Abdulkader, PhD|
|Sub-Investigator: Henk DF Schallig, PhD|
|Study Chair:||Amanuel Haile, MD||Mekelle University College of Health Sciences|