Cutaneous LeishmaniasesNCT03837431
Cutaneous Leishmaniasis Diagnostic Study
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
Trial summary
The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- Skin slit, Dental broach and Tape disc
- How many people
- 351 participants
- Where
- 1 siteEthiopia
- Study dates
- 13 Feb 2019to 31 Jan 2023
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting at the LRTC with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients. Very young children below the age of two are excluded as was done in other studies18 since the study does require more potentially painful procedures as compared to the routine diagnostic procedures.
Who may be able to join
- Clinical suspicion of CL
Who cannot join
- ≤ 2 years of age
- Not willing or able to provide consent/assent
- CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
- Co-morbidity with visceral leishmaniasis
- On CL treatment at time of enrollment
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Leishmania Research and Treatment Center, University of Gondar hospital
Gonder
About this study
Official title: Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia
The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.
Read the detailed description
Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.
The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- Skin slit, Dental broach, Tape disc
- Keywords
- Cutaneous, Leishmaniasis, Ethiopia, RDT
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin slitDiagnostic test
Skin slit microscopy, RDT and PCR
Dental broachDiagnostic test
Dental broach RDT and PCR
Tape discDiagnostic test
Tape disc PCR
| Study group | Role | What they receive |
|---|---|---|
| CL suspicion | Individuals presenting with clinical suspicion of CL Receives: Diagnostic Test: Skin slit; Diagnostic Test: Dental broach; Diagnostic Test: Tape disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity of CL detect Rapid Test using skin slit sampling
% test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)
Measured: February 2019
Secondary outcomes (8)
Sensitivity, specificity of CL detect Rapid Test using dental broach sampling
CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling
Measured: February 2019
Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling
CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample
Measured: May 2018
Sensitivity, specificity of CL detect Rapid Test compared to routine
CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample
Measured: February 2019
Sensitivity, specificity of dental broach sample compared to skin slit sample
PCR with dental broach compared to PCR with skin slit sample
Measured: February 2019
Sensitivity, specificity of tape disc sampling
PCR with tape disc sampling compared to PCR with skin slit sampling
Measured: February 2019
Sensitivity, specificity of routine testing
Microscopy with skin slit sampling compared to PCR with skin slit sampling
Measured: February 2019
Species identification
For selected CL lesions species identification will be done
Measured: February 2019
Immunomodulatory mediators in CL lesions using non-invasive sampling
Tape disc samples will be used and correlation with lesion severity will be assessed
Measured: February 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start13 Feb 2019
- Primary completion12 Aug 2022
- Study completion31 Jan 2023
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 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
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan van Griensven, MD, PhD, Study chair, Institute of Tropical Medicine, Antwerp, BelgiumRezika Mohammed, MD, Principal investigator, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837431
- Sponsor's protocol ID
- 1219/18
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD accessible by managed access
Publications
van Henten S, Fikre H, Melkamu R, Dessie D, Mekonnen T, Kassa M, Bogale T, Mohammed R, Cnops L, Vogt F, Pareyn M, van Griensven J. Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis. PLoS Negl Trop Dis. 2022 Jan 18;16(1):e0010143. doi: 10.1371/journal.pntd.0010143. eCollection 2022 Jan.
PubMed 35041672
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. 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 Ethiopia
- ClinicalTrials.gov ID
- NCT03837431
- Acronym / sponsor ID
- 1219/18
- Conditions
- Cutaneous Leishmaniases
- Keywords
- Cutaneous, Leishmaniasis, Ethiopia, RDT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 12 Feb 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.
The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.
Detailed description
Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.
The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL suspicion | – | Diagnostic Test: Skin slit, Diagnostic Test: Dental broach, Diagnostic Test: Tape discIndividuals presenting with clinical suspicion of CL |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting at the LRTC with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients. Very young children below the age of two are excluded as was done in other studies18 since the study does require more potentially painful procedures as compared to the routine diagnostic procedures.
Key inclusion criteria (1 listed)
- Clinical suspicion of CL
Key exclusion criteria (5 listed)
- ≤ 2 years of age
- Not willing or able to provide consent/assent
- CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
- Co-morbidity with visceral leishmaniasis
- On CL treatment at time of enrollment
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 |
|---|---|---|
| Skin slitSkin slit microscopy, RDT and PCR | Diagnostic test | CL suspicion |
| Dental broachDental broach RDT and PCR | Diagnostic test | CL suspicion |
| Tape discTape disc PCR | Diagnostic test | CL suspicion |
Primary outcome
Sensitivity, specificity of CL detect Rapid Test using skin slit sampling
Time frame: February 2019
% test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)
8 secondary outcomes
Sensitivity, specificity of CL detect Rapid Test using dental broach sampling
Time frame: February 2019
Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling
Time frame: May 2018
Sensitivity, specificity of CL detect Rapid Test compared to routine
Time frame: February 2019
Sensitivity, specificity of dental broach sample compared to skin slit sample
Time frame: February 2019
Sensitivity, specificity of tape disc sampling
Time frame: February 2019
Sensitivity, specificity of routine testing
Time frame: February 2019
Species identification
Time frame: February 2019
Immunomodulatory mediators in CL lesions using non-invasive sampling
Time frame: February 2019
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 1 Mar 2023.
- Derived from this study: PubMed 35041672van Henten S, Fikre H, Melkamu R, Dessie D, Mekonnen T, Kassa M, Bogale T, Mohammed R, Cnops L, Vogt F, Pareyn M, van Griensven J. Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis. PLoS Negl Trop Dis. 2022 Jan 18;16(1):e0010143. doi: 10.1371/journal.pntd.0010143. eCollection 2022 Jan.
- Individual participant dataSharing planned: Yes. IPD accessible by managed access
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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.
Johan van Griensven, MD, PhD study chair
Institute of Tropical Medicine, Antwerp, Belgium
Rezika Mohammed, MD principal investigator
College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
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 Ethiopia.
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 1 inclusion and 5 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 1 Mar 2023. 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 Ethiopia. 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?
Sensitivity, specificity of CL detect Rapid Test using skin slit sampling (time frame: February 2019). 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 NCT03837431, 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 1 Mar 2023.