Skip to main content
OpenTrials
Completed

NCT Number: NCT03435419

Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cutaneous Leishmaniases Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LoopampTM Leishmania Detection Kit

Diagnostic Test

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

CL DetectTM Rapid Test

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan

Acronym: CLeishPOCAFG

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 19, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.