Clinical trial NCT02979002: Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
Official title: Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Leishmaniasis
Skin Diseases, Parasitic
Neglected Diseases
Lead sponsor: National School of Public Health, Morocco
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2016-12-01
Enrollment: 219
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary health centers 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Positive result for this test
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Erfoud
country: Morocco
facility: Primary Health center
state: Errachidia
city: Tinejdad
country: Morocco
facility: Health primary center
state: Errachidia
city: Sekoura
country: Morocco
facility: Primary Health Center
state: Ouarzazates
city: Tarmight
country: Morocco
facility: Primary Health Center
state: Ouarzazates
city: Tazouta
country: Morocco
facility: Primary Health Center
state: Sefrou
city: Boumalne
country: Morocco
facility: Primary Health Center
state: Tinghir
city: Kelaat Mgouna
country: Morocco
facility: Primary Health Center
state: Tinghir
city: Sefrou
country: Morocco
facility: Primary Health Center
city: Sidi Kacem
country: Morocco
facility: Primary Health Center
Study officials:
affiliation: National School of Public Health - Rabat - Morocco
name: Issam Bennis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.