Cutaneous LeishmaniasisNCT02979002
Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
An observational study of Cutaneous Leishmaniasis and Skin Diseases, Parasitic, run by National School of Public Health, Morocco at 9 sites in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Leishmaniasis, Skin Diseases, Parasitic, Neglected Diseases
- How many people
- 219 participants
- Where
- 9 sitesMorocco
- Study dates
- Dec 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary health centers in Morocco
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Morocco9 sites
Primary Health center
Arfoud, Errachidia
Primary Health Center
Boumalne Dades, Tinghir
Primary Health Center
Kelaat Mgouna, Tinghir
Primary Health Center
Sefrou
Primary Health Center
Sekoura, Ouarzazates
Primary Health Center
Sidi Kacem
Primary Health Center
Tarmight, Ouarzazates
Primary Health Center
Tazouta, Sefrou
Health primary center
Tinajdad, Errachidia
About this study
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.
Read the 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.
- Medical subject headings
- Leishmaniasis, Cutaneous, Skin Diseases, Parasitic, Neglected Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive result for this test
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- National School of Public Health, Morocco
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Principal investigator, Issam Bennis, MD, National School of Public Health, Morocco
- Investigators
- Issam Bennis, MD, MPH, Principal investigator, National School of Public Health - Rabat - Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979002
- Sponsor's protocol ID
- ENSP276/DGDB26012016
- Status last verified
- Aug 2017
- First submitted
- 29 Nov 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 29988004
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
- ClinicalTrials.gov ID
- NCT02979002
- Acronym / sponsor ID
- ENSP276/DGDB26012016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- National School of Public Health, MoroccoUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary health centers in Morocco
Key inclusion criteria (6 listed)
- 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 :
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive result for this test
Time frame: 50 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Derived from this study: PubMed 29988004Bennis 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cutaneous Leishmaniasis
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
Cutaneous Leishmaniasis, Pain
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
Not yet recruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Cutaneous Leishminiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Bennis, MD, MPH principal investigator
National School of Public Health - Rabat - Morocco
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniasis and Skin Diseases, Parasitic, run by National School of Public Health, Morocco at 9 sites in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive result for this test (time frame: 50 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.