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

Completed

• Conditions: Cutaneous Leishmaniases
• Interventions: Diagnostic Test: LoopampTM Leishmania Detection Kit; Diagnostic Test: CL DetectTM Rapid Test

• Registration Number: NCT03435419
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

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.

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.

Study Timeline

• Study Start: 2016-04-16
• Primary Completion: 2016-06-22
• Study Completion: 2016-07-18
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CL suspects	CL DetectTM Rapid Test	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.
CL suspects	LoopampTM Leishmania Detection Kit	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit	Through study completion, an average of 6 months	Sensitivity and Specificity of the two diagnostic tests