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CompletedNCT03435419CLeishPOCAFGUpdated Feb 19, 2018

Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan

An observational study in Cutaneous Leishmaniases, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
274
Ages
2 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Cutaneous Leishmaniases

Keywords

  • cutaneous leishmaniasis
  • RDT
  • LAMP
  • PCR
03

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Clinical signs compatible with cutaneous leishmaniasis
  • Age ≥ than two years old.
  • Informed consent obtained and documented.
  • Clinical samples can be obtained.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
274 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Diagnostic Test: LoopampTM Leishmania Detection Kit · Diagnostic Test: CL DetectTM Rapid Test

Interventions

  • Diagnostic testLoopampTM Leishmania Detection Kit

    LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection

  • Diagnostic testCL DetectTM Rapid Test

    CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection

05

What researchers measure

Primary outcomes

  1. Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit

    Sensitivity and Specificity of the two diagnostic tests

    Time frame: Through study completion, an average of 6 months

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Study locations

No study locations are listed for this record.

07

References and documents

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 22693548 ↗
  • Eroglu 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 25223940 ↗
  • Marfurt 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 12843055 ↗
  • Masmoudi 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 23858338 ↗
  • Notomi 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 10871386 ↗
  • Reithinger 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 17714672 ↗
  • De 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03435419
Lead sponsor
Foundation for Innovative New Diagnostics, Switzerland
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Apr 16, 2016
Primary completion
Jun 22, 2016
Completion
Jul 18, 2016
Last update
Feb 19, 2018

Study contacts

Martijn Vink, MD, MPH
principal investigator · HealthNet TPO
Israel Cruz, PhD
study director · Foundation for Innovative New Diagnostics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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