Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
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|ClinicalTrials.gov Identifier: NCT03762070|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment|
|Leishmaniasis, Cutaneous||Device: CL Detect™ Rapid Test|
Observational study of a FDA cleared device, the CL Detect™ Rapid Test. Data for the 510(K) was supported by a sensitivity study conducted in Tunisia, Old world Leishamania major and a specificity study conducted in the United Sates. Sensitivity and specificity data collected recently in Peru (2014-2015), by the Instituto de Medicina Tropical Alexander von Humbolt, supports the idea that the sensitivity of the CL Detect™ Rapid Test can be drastically increased for New World Leishmania species. The study is a single trial, with two clinical sites, NAMRU-6, Puerto Maldonado and the Alexander von Humboldt Tropical Medicine Institute in Lima. The objective of the study is to determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test, using an optimized test procedure determined from a pilot study conducted in Peru. Two modifications to the test procedure (marketed device instructions) are included in this study: 1) increase in extraction time in lysis buffer from 5 to 10 minutes to 20 to 30 minutes and 2) a 20 μl increase in the volume of the sample to add to the test strip, from 20 μl to 40 μl. The gold standard for Leishmania diagnosis, which is microscopic identification of amastigotes in stained lesion sample, will be used as a control.
Participants will be patients who present for medical consultation due to a suspected CL lesion. After obtaining informed consent and screening the participant for eligibility, we will collect and test at most 4 samples from the index lesion in the following order:
- one sample obtained with a dental broach for use with the CL Detect™ Rapid Test;
- one sample obtained by scraping for microscopic identification of amastigotes; and
- one sample obtained by scraping for Leishmania speciation by PCR; and
- when possible, (depending on the size of the lesion), one sample from a different site of the same lesion, obtained by scraping for use with the CL Detect™ Rapid Test. PCR analysis will be performed by NAMRU-6 for possible exploratory analyses including species identification. If the etiologies of the lesions that are negative for Leishmania are known, they will be reported. Participants with a positive diagnosis of leishmaniasis by microscopy or other methods will be referred for standard of care treatment in Peru by the attending physician of the Peruvian Ministry of Health. Treatment is not part of this study. If a participant's lesions are negative for Leishmania, standard of care follow-up testing will be performed, either at the study site, or (when indicated) in another hospital.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru|
|Actual Study Start Date :||October 2, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||April 2019|
- Device: CL Detect™ Rapid Test
Observational study of a FDA cleared device, the CL Detect™ Rapid Test.
- The performance (sensitivity and specificity) of the CL Detect™ Rapid Test [ Time Frame: 1 day ]Sensitivity and specificity of CL Detect™ Rapid Test will be determined by comparing with the gold standard, microscopy of stained lesion samples for identification of Leishmania amastigotes. The following definitions apply to the calculation of assay sensitivity and specificity: 1. True positive: Positive by both the CL Detect™ Rapid Test and the reference method. 2. False positive: Positive by the CL Detect™ Rapid Test but negative for the reference method. 3. True negative: Negative by both the CL Detect™ Rapid Test and the reference method. 4. False negative: Negative by the CL Detect™ Rapid Test but positive for the reference method.
- Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples. [ Time Frame: 1 day ]Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762070
|Contact: Max Grogl, Ph.D.||firstname.lastname@example.org|
|Universidad Peruana Cayetano Heredia (UPCH)||Recruiting|
|Contact: Ana Ramos, M.D. email@example.com|
|Sub-Investigator: Alejandro Llanos-Cuentas, M.D., Ph.D|
|U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6)||Recruiting|
|Puerto Maldonado, Peru|
|Contact: Luis Angel Rosales 51-982-328-888|
|Principal Investigator:||Max Grogl, Ph.D.||Scientific Director|