Cutaneous Leishmaniasis Diagnostic Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Leishmaniases
• Intervention / Treatment: Diagnostic test: Skin slit; Diagnostic test: Dental broach; Diagnostic test: Tape disc

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 Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• Ethiopia
  • Gondar, Ethiopia
    • Leishmania Research and Treatment Center, University of Gondar hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting at the LRTC with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients. Very young children below the age of two are excluded as was done in other studies18 since the study does require more potentially painful procedures as compared to the routine diagnostic procedures.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium

Publications and helpful links

General Publications

• van Henten S, Fikre H, Melkamu R, Dessie D, Mekonnen T, Kassa M, Bogale T, Mohammed R, Cnops L, Vogt F, Pareyn M, van Griensven J. Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis. PLoS Negl Trop Dis. 2022 Jan 18;16(1):e0010143. doi: 10.1371/journal.pntd.0010143. eCollection 2022 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Ethiopia; Leishmaniasis; Cutaneous; RDT
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous
• Other Study ID Numbers: 1219/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD accessible by managed access
• IPD Sharing Time Frame: After completion of the primary publication
• IPD Sharing Access Criteria: Applicants will need to fill out a data access request form
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No