Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

NCT01865032 | Completed Results

• 1 other identifier: S-12-19
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Diseases

Keywords

Leishmaniasis, Leishmania

Outcome Measures

Primary Outcomes (6)

• True Positive

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

  within 1 hour after samples are taken

• False Positive

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

  within 1 hour after samples are taken

• True Negative

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

  within 1 hour after samples are taken

• False Negative

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

  within 1 hour after samples are taken

• Specificity

  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.

  within 1 hour after samples are taken

• False Positive Rate

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

  within 1 hour after samples are taken

Study Arms (1)

Skin Ulcers

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Dermatology clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InBios International, Inc.: collaborator
• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

dental broach samples in lysis buffer

MeSH Terms

Conditions

Skin Diseases; Leishmaniasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Giselle Singer
• Organization: Mount Sinai School of Medicine

giselle.signer@mssm.edu

212-241-3288

Study Officials

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 30, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2014
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Locations

US (1)