Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02979002
• Date of registration: 29/11/2016
• Prospective Registration: Yes
• Primary sponsor: National School of Public Health, Morocco
• Public title: Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
• Scientific title: Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
• Date of first enrolment: December 2016
• Target sample size: 219
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02979002
• Study type: Observational
• Phase: N/A

Countries of recruitment

Morocco

Contacts

• Name: Issam Bennis, MD, MPH
• Affiliation: National School of Public Health - Rabat - Morocco

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cutaneous Leishmaniasis

Neglected Diseases

Skin Diseases, Parasitic

Primary Outcome(s)

Positive result for this test [Time Frame: 50 minutes]

Secondary ID(s)

ENSP276/DGDB26012016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institute of Tropical Medicine, Belgium