N/A
Completed N=168
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
Skin Diseases, Parasitic
Source: ClinicalTrials.gov NCT01769612 ↗
Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results — 147; 144; 96 Participants
Summary
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results |
147; 144; 96 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01769612). 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. Informational only — not medical advice.