Skin Diseases
Conditions
Keywords
Leishmaniasis, Leishmania
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.
Detailed description
Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.
Interventions
None listed
Sponsors
U.S. Army Medical Research and Development Command
InBios International, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Positive | within 1 hour after samples are taken | Positive by both the CL Detect™ Rapid Test and microscopy of an index lesion smear for amastigotes. |
| False Positive | within 1 hour after samples are taken | Positive by the CL Detect™ Rapid Test but negative for Microscopy |
| True Negative | within 1 hour after samples are taken | Negative by both the CL Detect™ Rapid Test device and Microscopy |
| False Negative | within 1 hour after samples are taken | Negative by the CL Detect™ Rapid Test but positive for Microscopy |
| Specificity | within 1 hour after samples are taken | 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. |
| False Positive Rate | within 1 hour after samples are taken | False positive rate (type 1 error, calculated as 1-specificity) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark Lebwohl, MD
Icahn School of Medicine at Mount Sinai
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 20 |
| Lesion Age | 17.8 days STANDARD_DEVIATION 25 |
| Lesion Characteristics Nodular | 3 Participants |
| Lesion Characteristics Secondary bacterial infection | 31 Participants |
| Lesion Characteristics Ulcerated | 150 Participants |
| Lesion Location Abdomen | 3 Participants |
| Lesion Location Arm | 8 Participants |
| Lesion Location Back | 13 Participants |
| Lesion Location Back of Head | 4 Participants |
| Lesion Location Buttocks | 3 Participants |
| Lesion Location Face | 25 Participants |
| Lesion Location Foot | 24 Participants |
| Lesion Location Hand | 19 Participants |
| Lesion Location Leg | 42 Participants |
| Lesion Location Upper Torso | 9 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants |
| Race/Ethnicity, Customized White | 121 Participants |
| Region of Enrollment United States | 150 participants |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 150 |
| other Total, other adverse events | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
None listed