NCT03435419

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2016

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

February 5, 2018

Last Update Submit

February 9, 2018

Conditions

Cutaneous Leishmaniases

Keywords

cutaneous leishmaniasisRDTLAMPPCR

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit

    Sensitivity and Specificity of the two diagnostic tests

    Through study completion, an average of 6 months

Study Arms (1)

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 KitDiagnostic Test: CL DetectTM Rapid Test

Interventions

LoopampTM Leishmania Detection KitDIAGNOSTIC_TEST

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

CL suspects
CL DetectTM Rapid TestDIAGNOSTIC_TEST

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

CL suspects

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 22693548BACKGROUND

  • 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.

    PMID: 25223940BACKGROUND

  • 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.

    PMID: 12843055BACKGROUND

  • 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.

    PMID: 23858338BACKGROUND

  • 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.

    PMID: 10871386BACKGROUND

  • 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.

    PMID: 17714672BACKGROUND

  • 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.

    PMID: 29135995BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Skin samples from cutaneous lesions obtained with a dental broach. Sample stored in lysis buffer accompanying the RDT kit. DNA extracted using commercial kit.

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Martijn Vink, MD, MPH

    HealthNet TPO

    PRINCIPAL INVESTIGATOR

  • Israel Cruz, PhD

    Foundation for Innovative New Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 19, 2018

Study Start

April 16, 2016

Primary Completion

June 22, 2016

Study Completion

July 18, 2016

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share