Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
1 other identifier
observational
219
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 8, 2017
August 1, 2017
8 months
November 29, 2016
August 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Positive result for this test
50 minutes
Eligibility Criteria
Primary health centers in Morocco
You may qualify if:
- Participants with suspected Cutaneous Leishmaniasis wound(s) in apparently healthy state
- Who is able to learn the Information sheet and sign the Informed consent form by them selves or by their parents with the presence or not of a witness (for illiterate people)
- Who satisfy the following criteria :
- with an ulcerative lesion in any accessible part of the body to perform the dental broach and the scraping.
- Just one ulcerative lesion by patient could be selected (The newest and the less infected)
- Lesion should be less than 04 months of age
You may not qualify if:
- Patients with only nodular, papular, macular or nodulo-papular suspected CL forms
- Patients with ulcerative lesions with a suspected bacteria origin which could disappear after a short course of antibiotic treatment.
- Patients who already received during the last two months, prior to signing the consent, a physical treatment (e.g. cryotherapy, thermotherapy, Laser) or a traditional treatment (e.g. burn, acide, traditional scraping)
- Patients presenting other disease with the need to take anti-parasite treatments
- Patient with a acute or chronic disease needing hospitalization
- Patient who already received antimoniate treatment incomplete or complete duration and dose against CL
- Any situation that could engage the security of the patient or of the health professional (e.g. People with a psychiatric trouble or a mental handicap )
- For children less than 12 years old, the decision of participation is mainly based on the condition that their parents are able to learn and understand the information sheet and sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Primary Health center
Arfoud, Errachidia, Morocco
Health primary center
Tinajdad, Errachidia, Morocco
Primary Health Center
Sekoura, Ouarzazates, Morocco
Primary Health Center
Tarmight, Ouarzazates, Morocco
Primary Health Center
Tazouta, Sefrou, Morocco
Primary Health Center
Boumalne Dades, Tinghir, Morocco
Primary Health Center
Kelaat Mgouna, Tinghir, Morocco
Primary Health Center
Sefrou, Morocco
Primary Health Center
Sidi Kacem, Morocco
Related Publications (1)
Bennis I, Verdonck K, El Khalfaoui N, Riyad M, Fellah H, Dujardin JC, Sahibi H, Bouhout S, Van der Auwera G, Boelaert M. Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco. Am J Trop Med Hyg. 2018 Sep;99(3):716-722. doi: 10.4269/ajtmh.18-0066. Epub 2018 Jul 5.
PMID: 29988004DERIVED
Biospecimen
Suspected Cutaneous leishmaniasis lesions
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Issam Bennis, MD, MPH
National School of Public Health - Rabat - Morocco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 1, 2016
Study Start
December 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 8, 2017
Record last verified: 2017-08