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Cutaneous Leishmaniasis Diagnostic Study

NCT03837431 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 351

Last updated 2023-03-01

No results posted yet for this study

Summary

The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.

Conditions

  • Cutaneous Leishmaniases

Interventions

DIAGNOSTIC_TEST

Skin slit

Skin slit microscopy, RDT and PCR

DIAGNOSTIC_TEST

Dental broach

Dental broach RDT and PCR

DIAGNOSTIC_TEST

Tape disc

Tape disc PCR

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Johan van Griensven, MD, PhD · Institute of Tropical Medicine, Antwerp, Belgium

  • Rezika Mohammed, MD · College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2022-08-12
Completion
2023-01-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837431 on ClinicalTrials.gov