Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Vector Borne Diseases+8

+ Infections

+ Leishmaniasis

Over 2 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: April 2016
See protocol details

Summary

Principal SponsorFoundation for Innovative New Diagnostics, Switzerland
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 16, 2016

Actual date on which the first participant was enrolled.

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.

Official TitlePoint of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan
NCT03435419
Principal SponsorFoundation for Innovative New Diagnostics, Switzerland
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

274 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 2 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesInfectionsLeishmaniasisParasitic DiseasesProtozoan InfectionsSkin DiseasesSkin Diseases, InfectiousSkin Diseases, ParasiticLeishmaniasis, CutaneousSkin and Connective Tissue DiseasesEuglenozoa Infections

Criteria

4 inclusion criteria required to participate
Clinical signs compatible with cutaneous leishmaniasis
Age ≥ than two years old.
Informed consent obtained and documented.
Clinical samples can be obtained.
4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers