Cutaneous LeishmaniasesCLeishPOCAFGNCT03435419
Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan
An observational study of Cutaneous Leishmaniases, run by Foundation for Innovative New Diagnostics, Switzerland.
Trial summary
New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. 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?
- LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test
- How many people
- 274 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2016to 18 Jul 2016
- 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: CL suspects attending the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul will be invited to enroll the study. Samples from prospective participants will be subjected to standard diagnostic procedure (Giemsa's smear microscopy), as well as PCR (confirmation test to be performed at AMC, The Netherlands) and the two new tests under evaluation, in order to determine the diagnostic accuracy of LAMP and CL Detect.
Who may be able to join
- Clinical signs compatible with cutaneous leishmaniasis
- Age ≥ than two years old.
- Informed consent obtained and documented.
- Clinical samples can be obtained.
Who cannot join
- Age less than two years old.
- Failure to obtain and document informed consent.
- Cutaneous leishmaniasis suspects from whom, for any reason, the required clinical samples needed for the study cannot be obtained.
- Patients already receiving CL treatment at the time of enrolment.
About this study
Official title: Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan
New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.
Read the detailed description
The investigators enrolled 274 CL suspects in the study to determine the diagnostic performance of LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test for CL diagnosis in Afghanistan. The study was conducted at the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis Clinic in Kabul, Afghanistan.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- LoopampTM Leishmania Detection Kit, CL DetectTM Rapid Test
- Keywords
- cutaneous leishmaniasis, RDT, LAMP, PCR
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoopampTM Leishmania Detection KitDiagnostic test
LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection
CL DetectTM Rapid TestDiagnostic test
CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection
| Study group | Role | What they receive |
|---|---|---|
| CL suspects | Individuals with suggestive signs of cutaneous leishmaniasis presenting themselves at the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul, Afghanistan.
These will be tested by diagnostic tests under evaluation:
i) LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection ii) CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection And their performance compared against a reference combining microscopy and PCR. Receives: Diagnostic Test: LoopampTM Leishmania Detection Kit; Diagnostic Test: CL DetectTM Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit
Sensitivity and Specificity of the two diagnostic tests
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start16 Apr 2016
- Primary completion22 Jun 2016
- Study completion18 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martijn Vink, MD, MPH, Principal investigator, HealthNet TPOIsrael Cruz, PhD, Study director, Foundation for Innovative New Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435419
- Sponsor's protocol ID
- P08020-AFG
- Acronym
- CLeishPOCAFG
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.
PubMed 22693548Eroglu F, Uzun S, Koltas IS. Comparison of clinical samples and methods in chronic cutaneous leishmaniasis. Am J Trop Med Hyg. 2014 Nov;91(5):895-900. doi: 10.4269/ajtmh.13-0582. Epub 2014 Sep 15.
PubMed 25223940Marfurt J, Nasereddin A, Niederwieser I, Jaffe CL, Beck HP, Felger I. Identification and differentiation of Leishmania species in clinical samples by PCR amplification of the miniexon sequence and subsequent restriction fragment length polymorphism analysis. J Clin Microbiol. 2003 Jul;41(7):3147-53. doi: 10.1128/JCM.41.7.3147-3153.2003.
PubMed 12843055Masmoudi A, Hariz W, Marrekchi S, Amouri M, Turki H. Old World cutaneous leishmaniasis: diagnosis and treatment. J Dermatol Case Rep. 2013 Jun 30;7(2):31-41. doi: 10.3315/jdcr.2013.1135. Print 2013 Jun 30.
PubMed 23858338Notomi T, Okayama H, Masubuchi H, Yonekawa T, Watanabe K, Amino N, Hase T. Loop-mediated isothermal amplification of DNA. Nucleic Acids Res. 2000 Jun 15;28(12):E63. doi: 10.1093/nar/28.12.e63.
PubMed 10871386Reithinger R, Dujardin JC, Louzir H, Pirmez C, Alexander B, Brooker S. Cutaneous leishmaniasis. Lancet Infect Dis. 2007 Sep;7(9):581-96. doi: 10.1016/S1473-3099(07)70209-8.
PubMed 17714672De Silva G, Somaratne V, Senaratne S, Vipuladasa M, Wickremasinghe R, Wickremasinghe R, Ranasinghe S. Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani. PLoS One. 2017 Nov 14;12(11):e0187024. doi: 10.1371/journal.pone.0187024. eCollection 2017.
PubMed 29135995
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan
- ClinicalTrials.gov ID
- NCT03435419
- Acronym / sponsor ID
- CLeishPOCAFG / P08020-AFG
- Conditions
- Cutaneous Leishmaniases
- Keywords
- cutaneous leishmaniasis, RDT, LAMP, PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 22 Jun 2016 (actual)
- Study completion
- 18 Jul 2016 (actual)
- First posted
- 19 Feb 2018 (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.
New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.
Detailed description
The investigators enrolled 274 CL suspects in the study to determine the diagnostic performance of LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test for CL diagnosis in Afghanistan. The study was conducted at the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis Clinic in Kabul, Afghanistan.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL suspects | – | Diagnostic Test: LoopampTM Leishmania Detection Kit, Diagnostic Test: CL DetectTM Rapid TestIndividuals with suggestive signs of cutaneous leishmaniasis presenting themselves at the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul, Afghanistan. These will be tested by diagnostic tests under evaluation: i) LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection ii) CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection And their performance compared against a reference combining microscopy and PCR. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CL suspects attending the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul will be invited to enroll the study. Samples from prospective participants will be subjected to standard diagnostic procedure (Giemsa's smear microscopy), as well as PCR (confirmation test to be performed at AMC, The Netherlands) and the two new tests under evaluation, in order to determine the diagnostic accuracy of LAMP and CL Detect.
Key inclusion criteria (4 listed)
- Clinical signs compatible with cutaneous leishmaniasis
- Age ≥ than two years old.
- Informed consent obtained and documented.
- Clinical samples can be obtained.
Key exclusion criteria (4 listed)
- Age less than two years old.
- Failure to obtain and document informed consent.
- Cutaneous leishmaniasis suspects from whom, for any reason, the required clinical samples needed for the study cannot be obtained.
- Patients already receiving CL treatment at the time of enrolment.
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 |
|---|---|---|
| LoopampTM Leishmania Detection KitLoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection | Diagnostic test | CL suspects |
| CL DetectTM Rapid TestCL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection | Diagnostic test | CL suspects |
Primary outcome
Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit
Time frame: Through study completion, an average of 6 months
Sensitivity and Specificity of the two diagnostic tests
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 19 Feb 2018.
- Background: PubMed 22693548Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.
- Background: PubMed 25223940Eroglu F, Uzun S, Koltas IS. Comparison of clinical samples and methods in chronic cutaneous leishmaniasis. Am J Trop Med Hyg. 2014 Nov;91(5):895-900. doi: 10.4269/ajtmh.13-0582. Epub 2014 Sep 15.
- Background: PubMed 12843055Marfurt J, Nasereddin A, Niederwieser I, Jaffe CL, Beck HP, Felger I. Identification and differentiation of Leishmania species in clinical samples by PCR amplification of the miniexon sequence and subsequent restriction fragment length polymorphism analysis. J Clin Microbiol. 2003 Jul;41(7):3147-53. doi: 10.1128/JCM.41.7.3147-3153.2003.
- Background: PubMed 23858338Masmoudi A, Hariz W, Marrekchi S, Amouri M, Turki H. Old World cutaneous leishmaniasis: diagnosis and treatment. J Dermatol Case Rep. 2013 Jun 30;7(2):31-41. doi: 10.3315/jdcr.2013.1135. Print 2013 Jun 30.
- Background: PubMed 10871386Notomi T, Okayama H, Masubuchi H, Yonekawa T, Watanabe K, Amino N, Hase T. Loop-mediated isothermal amplification of DNA. Nucleic Acids Res. 2000 Jun 15;28(12):E63. doi: 10.1093/nar/28.12.e63.
- Background: PubMed 17714672Reithinger R, Dujardin JC, Louzir H, Pirmez C, Alexander B, Brooker S. Cutaneous leishmaniasis. Lancet Infect Dis. 2007 Sep;7(9):581-96. doi: 10.1016/S1473-3099(07)70209-8.
- Background: PubMed 29135995De Silva G, Somaratne V, Senaratne S, Vipuladasa M, Wickremasinghe R, Wickremasinghe R, Ranasinghe S. Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani. PLoS One. 2017 Nov 14;12(11):e0187024. doi: 10.1371/journal.pone.0187024. eCollection 2017.
- WHO. Control of the LeishmaniasesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Martijn Vink, MD, MPH principal investigator
HealthNet TPO
Israel Cruz, PhD study director
Foundation for Innovative New Diagnostics
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases, run by Foundation for Innovative New Diagnostics, Switzerland.
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 4 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit (time frame: Through study completion, an average of 6 months). 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 NCT03435419, which also lists 7 linked publications.
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 19 Feb 2018.