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Completed

NCT Number: NCT01865032

Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

About this study

Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.

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
  • Subject is able to give written informed consent
  • Subject has a skin ulcer that satisfies the following criteria for an index lesion:
  • less than 4 months in age
  • primarily ulcerative, not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
  • in a location suitable for collecting samples by dental broach and scraping
  • In the opinion of the investigator, the subject is capable of understanding and complying with the protocol

Exclusion criteria

  • Received treatment for leishmaniasis or any treatment to the lesion even if not previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod, thermotherapy, photodynamic therapy, within 2 months prior to signing the consent form, with the exception of mercurochrome

Treatment and study plan

Primary outcomes

  1. True Positive

    Time frame: within 1 hour after samples are taken

    Positive by both the CL Detect™ Rapid Test and microscopy of an index lesion smear for amastigotes.

  2. False Positive

    Time frame: within 1 hour after samples are taken

    Positive by the CL Detect™ Rapid Test but negative for Microscopy

  3. True Negative

    Time frame: within 1 hour after samples are taken

    Negative by both the CL Detect™ Rapid Test device and Microscopy

  4. False Negative

    Time frame: within 1 hour after samples are taken

    Negative by the CL Detect™ Rapid Test but positive for Microscopy

  5. Specificity

    Time frame: within 1 hour after samples are taken

    Negative Specificity was calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives.

  6. False Positive Rate

    Time frame: within 1 hour after samples are taken

    False positive rate (type 1 error, calculated as 1-specificity)

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Collaborators

  • InBios International, Inc.

Registry information

Official study title

Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 30, 2013
Registry last updated
Feb 25, 2026

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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