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Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01865032
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : September 8, 2014
InBios International, Inc.
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Brief Summary:
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. 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.

Condition or disease
Skin Diseases

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Skin Ulcers
Skin ulcers. No intervention. Subjects will be followed up by their respective primary providers.

Primary Outcome Measures :
  1. Specificity [ Time Frame: 1 hour ]
    Specificity will be presented for the CL Detect™ Rapid Test device against the reference method (microscopy). Specificity will be calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives times 100%.

Secondary Outcome Measures :
  1. False positive rate [ Time Frame: 1 hour ]
    α, type 1 error, calculated as 1-specificity times 100%

  2. False negative rate [ Time Frame: 1 hour ]
    β, type 2 error, calculated as 1-sensitivity times 100%

Biospecimen Retention:   Samples With DNA
dental broach samples in lysis buffer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Dermatology clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01865032

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United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
InBios International, Inc.
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Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: U.S. Army Medical Research and Development Command Identifier: NCT01865032     History of Changes
Other Study ID Numbers: S-12-19
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Skin Diseases
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious