NCT03837431

Cutaneous Leishmaniasis Diagnostic Study

Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 351 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear. The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.

Conditions

• Cutaneous Leishmaniases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-13
• Primary completion: 2022-08-12
• Completion: 2023-01-31
• First posted: 2019-02-12
• Last updated: 2023-03-01

Locations

1 site across 1 country: Ethiopia