Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases, Parasitic; Cutaneous Leishmaniasis; Neglected Diseases

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 Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• Morocco
  • Sefrou, Morocco
    • Primary Health Center
  • Sidi Kacem, Morocco
    • Primary Health Center
  • Errachidia
    • Erfoud, Errachidia, Morocco
      • Primary Health Center
    • Tinejdad, Errachidia, Morocco
      • Health primary center
  • Ouarzazates
    • Sekoura, Ouarzazates, Morocco
      • Primary Health Center
    • Tarmight, Ouarzazates, Morocco
      • Primary Health Center
  • Sefrou
    • Tazouta, Sefrou, Morocco
      • Primary Health Center
  • Tinghir
    • Boumalne, Tinghir, Morocco
      • Primary Health Center
    • Kelaat Mgouna, Tinghir, Morocco
      • Primary Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary health centers in Morocco

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive result for this test	50 minutes

Collaborators and Investigators

• Sponsor: National School of Public Health, Morocco
• Collaborators: Institute of Tropical Medicine, Belgium
• Investigators: Principal Investigator: Issam Bennis, MD, MPH, National School of Public Health - Rabat - Morocco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 6, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Vector Borne Diseases; Protozoan Infections; Skin Diseases, Infectious; Euglenozoa Infections; Skin Diseases; Leishmaniasis; Leishmaniasis, Cutaneous; Parasitic Diseases; Skin Diseases, Parasitic; Neglected Diseases
• Other Study ID Numbers: ENSP276/DGDB26012016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED