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

Overview

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.

Full Title of Study: “Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 22, 2016

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.

Interventions

  • Diagnostic Test: LoopampTM Leishmania Detection Kit
    • LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection
  • Diagnostic Test: CL DetectTM Rapid Test
    • CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection

Arms, 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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:

  • 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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Foundation for Innovative New Diagnostics, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martijn Vink, MD, MPH, Principal Investigator, HealthNet TPO
    • Israel Cruz, PhD, Study Director, Foundation for Innovative New Diagnostics

References

Alvar J, Vélez 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.

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.

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.

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.

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.

Reithinger R, Dujardin JC, Louzir H, Pirmez C, Alexander B, Brooker S. Cutaneous leishmaniasis. Lancet Infect Dis. 2007 Sep;7(9):581-96. Review.

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.

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