Skin Diseases, Parasitic
Conditions
Keywords
Leishmaniasis, Leishmania
Brief summary
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
Detailed description
Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.
Interventions
OTHERNo Intervention
Sponsors
InBios International, Inc.
Institut Pasteur of Tunis, Tunisia
U.S. Army Medical Research and Development Command
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results | within 1 hour after taking samples | Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis. |
Countries
Tunisia
Participant flow
Recruitment details
168 subjects were enrolled in the regions of Sidi Bouzid and Gafsa, Tunisia
Participants by arm
| Arm | Count |
|---|---|
| CL Detect Rapid Test and Microsopy Samples Samples taken to be evaluated in the CL Detect and Microscopy assays
No Intervention | 168 |
| Total | 168 |
Baseline characteristics
| Characteristic | CL Detect Rapid Test and Microsopy Samples |
|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 15.8 |
| Lesion Age | 36.2 days STANDARD_DEVIATION 22.6 |
| Lesion Characteristics Nobular | 0 Participants |
| Lesion Characteristics Secondary bacterial infection | 74 Participants |
| Lesion Characteristics Ulcerated | 168 Participants |
| Lesion Location Abdomen | 0 Participants |
| Lesion Location Arm | 55 Participants |
| Lesion Location Back of head | 1 Participants |
| Lesion Location Face | 4 Participants |
| Lesion Location Foot | 35 Participants |
| Lesion Location Hand | 14 Participants |
| Lesion Location Leg | 59 Participants |
| Race/Ethnicity, Customized North African | 168 Participants |
| Region of Enrollment Tunisia | 168 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 168 |
| other Total, other adverse events | 0 / 168 |
| serious Total, serious adverse events | 0 / 168 |
Outcome results
Primary
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.
Time frame: within 1 hour after taking samples
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CL Detect Rapid Test | Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results | 147 Participants |
| Microscopy | Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results | 144 Participants |
| Culture | Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results | 96 Participants |