N/A
N=168
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
Skin Diseases, Parasitic
Bottom Line
View on ClinicalTrials.gov: NCT01769612 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results — 147; 144; 96 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- 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 Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results |
147; 144; 96 | — |
Summary
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
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.