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Completed

NCT Number: NCT01769612

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

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

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Key information

Conditions

Skin Diseases, Parasitic Euglenozoa Infections Infections Leishmaniasis Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Primary Health Clinic, Gafsa, Gafsa Governorate, Tunisia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

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

    Time frame: within 1 hour after taking samples

    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.

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Collaborators

  • InBios International, Inc.
  • Institut Pasteur of Tunis, Tunisia

Registry information

Official study title

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

Acronym: CL Detect™

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 16, 2013
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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