Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

U.S. Army Medical Research and Development Command168 enrolled

Overview

The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Skin Diseases, Parasitic

Interventions

No InterventionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years of age and generally healthy * Subject able to give written informed consent * Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion: * less than 4 months in age * primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis * in a location suitable for collecting samples by dental broach, scraping, and aspiration * In the opinion of the investigator, the subject is capable of understanding and complying with the protocol Exclusion Criteria: • Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome

Locations (2)

Primary Health Clinic

Gafsa, Gafsa Governorate, Tunisia

Primary Health Clinics

Sidi Bouzid, Sidi Bouzid Governorate, Tunisia

Outcomes

Primary Outcomes

Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results

Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.

Time frame: within 1 hour after taking samples

Data from ClinicalTrials.gov

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