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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-16

Study Completion Date

2016-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

NCT01865032

Skin Diseases

COMPLETED

Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa

NCT03646981

Leishmaniasis, Visceral

COMPLETED

Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen

NCT00633009

Cutaneous Leishmaniasis

COMPLETED PHASE2

Point of Care Testing for Presence of Current and or Previous T. Gondii Infection

NCT04474132

Toxoplasma Infections

RECRUITING NA

Novel Interventions and Diagnostic Tests for Leprosy

NCT06222372

Leprosy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous Leishmaniases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

LoopampTM Leishmania Detection Kit

Intervention Type DIAGNOSTIC_TEST

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

CL DetectTM Rapid Test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LoopampTM Leishmania Detection Kit

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

Intervention Type DIAGNOSTIC_TEST

CL DetectTM Rapid Test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No