Cutaneous LeishmaniasesRapidLeishNCT04001335
Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial summary
Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- Dental Broach
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Aug 2019to 1 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspicion of CL will be screened for inclusion.
Who may be able to join
- Skin biopsy for leishmania test requested by treating ITM clinician OR
- externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation <7 days of the biopsy sample
- willing and able to provide consent/assent
- not on CL treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches.
At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks.
Read more
The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing.
How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- Dental Broach
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental BroachDiagnostic test
Dental broach, RDT and PCR
| Study group | Role | What they receive |
|---|---|---|
| CL suspicion | Patients with skin lesions suspected to be cutaneous leishmaniasis Receives: Diagnostic Test: Dental Broach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CL detect RDT
Against combined reference of microscopy and PCR using skin punch biopsy
Measured: 2019-2010
Secondary outcomes (2)
Proportion of PCR positives on dental broach sample
Compared to PCR positives on skin punch biopsy
Measured: 2019-2020
Proportion of successful species typing on dental broach sample
Compared to successful species typing on skin punch biopsy sample
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start12 Aug 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: No patient recruitment possible during COVID-19, inavailability RDTs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasesStudies 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
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia van Henten, MD, Principal investigator, Institute of Tropical MedicineJohan van Griensven, MD,PhD, Study director, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001335
- Sponsor's protocol ID
- 1298/19
- Acronym
- RapidLeish
- Status last verified
- Mar 2021
- First submitted
- 26 Jun 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
- ClinicalTrials.gov ID
- NCT04001335
- Acronym / sponsor ID
- RapidLeish / 1298/19
- Conditions
- Cutaneous Leishmaniases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No patient recruitment possible during COVID-19, inavailability RDTs
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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.
Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches.
At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks.
The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing.
How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL suspicion | – | Diagnostic Test: Dental BroachPatients with skin lesions suspected to be cutaneous leishmaniasis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspicion of CL will be screened for inclusion.
Key inclusion criteria (4 listed)
- Skin biopsy for leishmania test requested by treating ITM clinician OR
- externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation <7 days of the biopsy sample
- willing and able to provide consent/assent
- not on CL treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental BroachDental broach, RDT and PCR | Diagnostic test | CL suspicion |
Primary outcome
Diagnostic accuracy of CL detect RDT
Time frame: 2019-2010
Against combined reference of microscopy and PCR using skin punch biopsy
2 secondary outcomes
Proportion of PCR positives on dental broach sample
Time frame: 2019-2020
Proportion of successful species typing on dental broach sample
Time frame: 2019-2020
Results and safety
The study was stopped early (reason given: No patient recruitment possible during COVID-19, inavailability RDTs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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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.
Saskia van Henten, MD principal investigator
Institute of Tropical Medicine
Johan van Griensven, MD,PhD study director
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was stopped early (reason given: No patient recruitment possible during COVID-19, inavailability RDTs). Results are not available in the source record.
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?
Diagnostic accuracy of CL detect RDT (time frame: 2019-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2021.