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Trial record 29 of 636 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT03435419
Recruitment Status : Completed
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cutaneous Leishmaniases Diagnostic Test: LoopampTM Leishmania Detection Kit Diagnostic Test: CL DetectTM Rapid Test

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.

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Study Type : Observational
Actual Enrollment : 274 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan
Actual Study Start Date : April 16, 2016
Actual Primary Completion Date : June 22, 2016
Actual Study Completion Date : July 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Chlorine

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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Skin samples from cutaneous lesions obtained with a dental broach. Sample stored in lysis buffer accompanying the RDT kit. DNA extracted using commercial kit.


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435419


Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
Investigators
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Principal Investigator: Martijn Vink, MD, MPH HealthNet TPO
Study Director: Israel Cruz, PhD Foundation for Innovative New Diagnostics

Additional Information:
Publications:

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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03435419     History of Changes
Other Study ID Numbers: P08020-AFG
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
cutaneous leishmaniasis
RDT
LAMP
PCR

Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases