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

February 9, 2018 updated by: Foundation for Innovative New Diagnostics, Switzerland

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Investigators

  • Principal Investigator: Martijn Vink, MD, MPH, HealthNet TPO
  • Study Director: Israel Cruz, PhD, Foundation for Innovative New Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2016

Primary Completion (ACTUAL)

June 22, 2016

Study Completion (ACTUAL)

July 18, 2016

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08020-AFG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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