LAMP Assay for the Diagnosis of Visceral Leishmaniasis

NCT04003532 | Completed

• 1 other identifier: TMA2016SF-1437
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Leishmaniasis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

  17 days

• Number of participants correctly diagnosed as VL based on db-PCR-NALFIA technology

  Baseline

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dawit Wolday: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

Mekelle University College of Health Sciences

Mek'ele, Ethiopia

Location

Related Publications (3)

• 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.

  PMID: 34789175 RESULT

• 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.

  PMID: 34310340 RESULT

• 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.

  PMID: 34125865 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole-blood

MeSH Terms

Conditions

Leishmaniasis, Visceral; Disease

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanuel Haile, MD

  Mekelle University College of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: October 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

ET (1)