LAMP Assay for the Diagnosis of Visceral Leishmaniasis

Visceral Leishmaniasis Clinical Trial

— EvaLAMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003532
• Other study ID #: TMA2016SF-1437
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Mekelle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the of the loop-mediated amplification assay (LAMP) as a diagnostic as well as a Test-of-Cure (ToC) for visceral leishmaniasis (VL) in an endemic area in Ethiopia. Furthermore, we aim to further development of the direct-blood PCR-Nucleic Acid Lateral-Flow Immuno-Assay (dB-PCR-NALFIA) as a novel diagnostic tool for VL and its subsequent evaluation in the field.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical evidence consistent with VL confirmed by microscopy (+ culture) and/or PCR

Exclusion Criteria:

• Treatment with any anti-leishmanial drugs within the previous 3 months
• Not capable of understanding or complying with the study protocol
• Refusal to consent and participate in to the study

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Locations

Country	Name	City	State
Ethiopia	Mekelle University College of Health Sciences	Mekele

Sponsors (3)

Lead Sponsor	Collaborator
Prof. Dawit Wolday	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Ethiopia, 

References & Publications (3)

Hagos DG, Kebede Y, Abdulkader M, Nigus E, Gessesse Arefaine Z, Nega G, Schallig HDF, Wolday D. Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study. PLoS One. 2 — View Citation

Hagos DG, Kiros YK, Abdulkader M, Arefaine ZG, Nigus E, Schallig HHDF, Wolday D. Utility of the Loop-Mediated Isothermal Amplification Assay for the Diagnosis of Visceral Leishmaniasis from Blood Samples in Ethiopia. Am J Trop Med Hyg. 2021 Jul 26;105(4): — View Citation

Hagos DG, Schallig HDFH, Kiros YK, Abdulkadir M, Wolday D. Performance of rapid rk39 tests for the diagnosis of visceral leishmaniasis in Ethiopia: a systematic review and meta-analysis. BMC Infect Dis. 2021 Nov 17;21(1):1166. doi: 10.1186/s12879-021-0682 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants correctly diagnosed with VL as assessed by LAMP assay	Performance of the LAMP will be compared to gold- standard diagnostic procedures, including parasite detection and/or PCR-technology	Baseline
Primary	Number of participants treated for VL and identified as cured (ToC) at day 17 post-treatment based on the assessment by LAMP assay	LAMP will be compared to gold- standard diagnostic procedures, including parasite detection and/or PCR-technology	Baseline
Secondary	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	LAMP will be compared to gold-standard diagnostic procedures, including parasite detection and/or PCR-technology	17 days
Secondary	Number of participants correctly diagnosed as VL based on db-PCR-NALFIA technology	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.	Baseline