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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
Sponsor:
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Prof. Dawit Wolday, Mekelle University

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.

Condition or disease
Visceral Leishmaniasis

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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
Whole-blood


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
VL suspected cases will be recruited from Ayder Referral Hospital, Mekelle University College of Health Sciences - (MUCHS) in Mekelle City, the capital of Tigray Regional State in Northern Ethiopia, where VL is highly endemic in the area. Patients seeking care at the hospital will be eligible and screened for inclusion in the study.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Dawit Wolday, MD, PhD +251911208984 dawwol@gmail.com
Contact: Yazezew Kebede, MD +251910104423 yazezew@gmail.com

Locations
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Ethiopia
Mekelle University College of Health Sciences Recruiting
Mekele, Ethiopia
Contact: Dawit Wolday, MD, PhD    +251911208984    dawwol@gmail.com   
Contact: Yazezew Kebede, MD    +251910104422    yazezew@gmail.com   
Principal Investigator: Dawit Wolday, MD, PhD         
Sub-Investigator: Yazezew Kebede, MD         
Sub-Investigator: Mahmoud Abdulkader, PhD         
Sub-Investigator: Henk DF Schallig, PhD         
Sponsors and Collaborators
Prof. Dawit Wolday
European and Developing Countries Clinical Trials Partnership (EDCTP)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Study Chair: Amanuel Haile, MD Mekelle University College of Health Sciences
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Responsible Party: Prof. Dawit Wolday, Associate Professor of Medicine, Mekelle University
ClinicalTrials.gov Identifier: NCT04003532    
Other Study ID Numbers: TMA2016SF-1437
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for all primary and secondary outcome measures will be made available to anyone who submit requests.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After 12 months of completion of project
Access Criteria: Data access requests will be first reviewed by the project's steering committee to ensure that all requested analyses can be achieved with the available study data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dawit Wolday, Mekelle University:
Diagnosis
Test-of-Cure
HIV co-infection
Loop-mediated amplification assay
PCR
Nucleic-acid Lateral Flow Immunoassay
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases