Cutaneous Leishmaniasis Diagnostic Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cutaneous Leishmaniases

Intervention / Treatment
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* Diagnostic Test: Skin slit
* Diagnostic Test: Dental broach
* Diagnostic Test: Tape disc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CL suspicion<br>Individuals presenting with clinical suspicion of CL | Diagnostic Test: Skin slit<br>* Skin slit microscopy, RDT and PCR<br>Diagnostic Test: Dental broach<br>* Dental broach RDT and PCR<br>Diagnostic Test: Tape disc<br>* Tape disc PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | February 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | February 2019 | 
| Sensitivity, specificity of dental broach sample compared to skin slit sample | PCR with dental broach compared to PCR with skin slit sample | February 2019 | 
| Sensitivity, specificity of tape disc sampling | PCR with tape disc sampling compared to PCR with skin slit sampling | February 2019 | 
| Sensitivity, specificity of routine testing | Microscopy with skin slit sampling compared to PCR with skin slit sampling | February 2019 | 
| Species identification | For selected CL lesions species identification will be done | February 2019 | 
| Immunomodulatory mediators in CL lesions using non-invasive sampling | Tape disc samples will be used and correlation with lesion severity will be assessed | February 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDT, Cutaneous, Leishmaniasis, Ethiopia