Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-25 @ 5:21 PM
Study NCT ID:
NCT02979002
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2016-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
Sponsor:
National School of Public Health, Morocco
Organization:
Study Overview
Official Title:
Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: