Visceral Leishmaniasis Clinical Trial
— EvaLAMPOfficial 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
Verified date | December 2023 |
Source | Mekelle University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Mekelle University College of Health Sciences | Mekele |
Lead Sponsor | Collaborator |
---|---|
Prof. Dawit Wolday | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), European and Developing Countries Clinical Trials Partnership (EDCTP) |
Ethiopia,
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
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 |
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