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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

Tracking Information
First Submitted Date June 27, 2019
First Posted Date July 1, 2019
Last Update Posted Date August 10, 2020
Actual Study Start Date October 1, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 28, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title LAMP Assay for the Diagnosis of Visceral Leishmaniasis
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole-blood
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.
Condition Visceral Leishmaniasis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 28, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Dawit Wolday, MD, PhD +251911208984 dawwol@gmail.com
Contact: Yazezew Kebede, MD +251910104423 yazezew@gmail.com
Listed Location Countries Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04003532
Other Study ID Numbers TMA2016SF-1437
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Prof. Dawit Wolday, Mekelle University
Study Sponsor Prof. Dawit Wolday
Collaborators
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Study Chair: Amanuel Haile, MD Mekelle University College of Health Sciences
PRS Account Mekelle University
Verification Date August 2020