LAMP Assay for the Diagnosis of Visceral Leishmaniasis

NCT ID: NCT04003532

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2023-06-30

Brief 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.

Detailed 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.

Conditions

Visceral Leishmaniasis

Keywords

Diagnosis; Test-of-Cure; HIV co-infection; Loop-mediated amplification assay; PCR; Nucleic-acid Lateral Flow Immunoassay

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Prof. Dawit Wolday

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dawit Wolday

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amanuel Haile, MD

Role: STUDY_CHAIR

Mekelle University College of Health Sciences

Locations

Mekelle University College of Health Sciences

Mek'ele, , Ethiopia

Countries

Ethiopia

References

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/s12879-021-06826-w.

Reference Type: RESULT

PMID: 34789175 (View on PubMed)

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):1050-1055. doi: 10.4269/ajtmh.21-0334.

Reference Type: RESULT

PMID: 34310340 (View on PubMed)

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. 2021 Jun 14;16(6):e0253303. doi: 10.1371/journal.pone.0253303. eCollection 2021.

Reference Type: RESULT

PMID: 34125865 (View on PubMed)

Other Identifiers

TMA2016SF-1437

Identifier Type: -

Identifier Source: org_study_id