Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

NCT ID: NCT02979002

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 219 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-08-31

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.

Conditions

Cutaneous Leishmaniasis; Skin Diseases, Parasitic; Neglected Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

National School of Public Health, Morocco

OTHER

Sponsor Role: lead

Responsible Party

Issam Bennis, MD

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Issam Bennis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

National School of Public Health - Rabat - Morocco

Locations

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

Countries

Morocco

References

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.

Reference Type: DERIVED

PMID: 29988004 (View on PubMed)

Other Identifiers

ENSP276/DGDB26012016

Identifier Type: -

Identifier Source: org_study_id