Clinical Trial: Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

Brief Summary: The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a composite reference standard test (Direct examination of skin smears + PCR test) in patients with clinically suspected Cutaneous Leishmaniasis disease in Morocco.

Detailed Summary: Study participants are recruited in nine health centers located in fourthree CL endemic provinces. The RDT under evaluation (index test) is the CL Detect™ Rapid Test (InBios, USA); a membrane-based amastigote antigen (peroxidoxin) detection test. The reference standard consists of two tests: direct examination of skin smears and PCR. For each patient, the health professional takes one dental broach sample and four skin smear samples from a single lesion. The dental broach sample is used for the RDT, which is done once. The skin smear samples are sent to provincial laboratories for microscopy testing and to reference laboratories in Morocco and Belgium for PCR testing by ITS1 PCR, Hsp70 genotyping and parasite load determination. Readers of index and reference tests do not have access to clinical information or any other test results. The results of the test under evaluation (RDT) and the molecular tests (PCR) are not communicated to the patient or her/his physician, as case management has to follow current clinical guidelines.
Sponsor: National School of Public Health, Morocco

Current Primary Outcome: Positive result for this test [ Time Frame: 50 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National School of Public Health, Morocco

Dates:
Date Received: November 29, 2016
Date Started: December 2016
Date Completion: October 2017
Last Updated: December 13, 2016
Last Verified: December 2016