CompletedNot Applicable

LAMP Assay for the Diagnosis of Visceral Leishmaniasis

Ethiopia500 participantsStarted 2018-10-01

Plain-language 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.

Who can participate

Age range5 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants correctly diagnosed with VL as assessed by LAMP assay

Timeframe: Baseline

Number of participants treated for VL and identified as cured (ToC) at day 17 post-treatment based on the assessment by LAMP assay

Timeframe: Baseline

Trial details

NCT IDNCT04003532

SponsorProf. Dawit Wolday

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Visceral Leishmaniasis trials