Cutaneous Leishmaniasis Diagnostic Study

Institute of Tropical Medicine, Belgium

Status

Completed

Conditions

Cutaneous Leishmaniases

Treatments

Diagnostic Test: Skin slit

Diagnostic Test: Tape disc

Diagnostic Test: Dental broach

Study type

Observational

Funder types

Other

Identifiers

NCT03837431

1219/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

351 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical suspicion of CL

Exclusion criteria

≤ 2 years of age
Not willing or able to provide consent/assent
CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
Co-morbidity with visceral leishmaniasis
On CL treatment at time of enrollment