Cutaneous Leishmaniasis Diagnostic Study

Institute of Tropical Medicine, Belgium351 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

351

Conditions

Cutaneous Leishmaniases

Interventions

Skin slitDIAGNOSTIC_TEST

Skin slit microscopy, RDT and PCR

Dental broachDIAGNOSTIC_TEST

Dental broach RDT and PCR

Tape discDIAGNOSTIC_TEST

Tape disc PCR

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

Leishmania Research and Treatment Center, University of Gondar hospital

Gonder, Ethiopia

Outcomes

Primary Outcomes

Sensitivity, specificity of CL detect Rapid Test using skin slit sampling

% test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)

Time frame: February 2019

Secondary Outcomes

Sensitivity, specificity of CL detect Rapid Test using dental broach sampling

CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling

Time frame: February 2019

Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling

CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample

Time frame: May 2018

Sensitivity, specificity of CL detect Rapid Test compared to routine

CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample

Time frame: February 2019

Sensitivity, specificity of dental broach sample compared to skin slit sample

PCR with dental broach compared to PCR with skin slit sample

Time frame: February 2019

Sensitivity, specificity of tape disc sampling

PCR with tape disc sampling compared to PCR with skin slit sampling

Time frame: February 2019

Sensitivity, specificity of routine testing

Microscopy with skin slit sampling compared to PCR with skin slit sampling

Time frame: February 2019

Data from ClinicalTrials.gov

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