N/A
N=150
Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
Skin Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01865032 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: True Positive — 0 samples
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY True Positive |
— | — |
| PRIMARY False Positive |
6 | — |
| PRIMARY True Negative |
144 | — |
| PRIMARY False Negative |
— | — |
| PRIMARY Specificity |
96.0 | — |
| PRIMARY False Positive Rate |
4.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01865032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.