Cutaneous Leishmaniasis Diagnostic Study

Cutaneous Leishmaniases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837431
• Other study ID #: 1219/18
• Status: Completed
• Start date: February 13, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: January 31, 2023
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniases
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Diagnostic Test:
• Skin slit
Skin slit microscopy, RDT and PCR
• Dental broach
Dental broach RDT and PCR
• Tape disc
Tape disc PCR

Locations

Country	Name	City	State
Ethiopia	Leishmania Research and Treatment Center, University of Gondar hospital	Gondar

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sensitivity, specificity of dental broach sample compared to skin slit sample	PCR with dental broach compared to PCR with skin slit sample	February 2019
Secondary	Sensitivity, specificity of tape disc sampling	PCR with tape disc sampling compared to PCR with skin slit sampling	February 2019
Secondary	Sensitivity, specificity of routine testing	Microscopy with skin slit sampling compared to PCR with skin slit sampling	February 2019
Secondary	Species identification	For selected CL lesions species identification will be done	February 2019
Secondary	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