Cutaneous Leishmaniasis Diagnostic Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CL suspicion Individuals presenting with clinical suspicion of CL |
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
|
Outcome Measures
Primary Outcome Measures
- Sensitivity, specificity of CL detect Rapid Test using skin slit sampling [February 2019]
% test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)
Secondary Outcome Measures
- Sensitivity, specificity of CL detect Rapid Test using dental broach sampling [February 2019]
CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling
- Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling [May 2018]
CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample
- Sensitivity, specificity of CL detect Rapid Test compared to routine [February 2019]
CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample
- Sensitivity, specificity of dental broach sample compared to skin slit sample [February 2019]
PCR with dental broach compared to PCR with skin slit sample
- Sensitivity, specificity of tape disc sampling [February 2019]
PCR with tape disc sampling compared to PCR with skin slit sampling
- Sensitivity, specificity of routine testing [February 2019]
Microscopy with skin slit sampling compared to PCR with skin slit sampling
- Species identification [February 2019]
For selected CL lesions species identification will be done
- Immunomodulatory mediators in CL lesions using non-invasive sampling [February 2019]
Tape disc samples will be used and correlation with lesion severity will be assessed
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Leishmania Research and Treatment Center, University of Gondar hospital | Gondar | Ethiopia |
Sponsors and Collaborators
- Institute of Tropical Medicine, Belgium
Investigators
- Study Chair: Johan van Griensven, MD, PhD, Institute of Tropical Medicine, Antwerp, Belgium
- Principal Investigator: Rezika Mohammed, MD, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1219/18