Performance of RPA-LF for Cutaneous Leishmaniasis

NCT ID: NCT04500873

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-12-20

Brief Summary

CL is public health in the Americas, diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations and its access is limited.

Technical requirements of conventional molecular diagnostics and costs preclude their routine use in primary care facilities in rural areas. A recently developed method of Isothermal Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, has shown high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of the RPA-LF test in a laboratory reference center and field scenario with community participation.

Detailed Description

CL is public health in the Americas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries, which mainly occur in rural areas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries. Diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations, and sometimes it is necessary to perform confirmatory tests that are not available in endemic areas.

Several molecular diagnostic tests have been developed for the diagnosis of CL, however, the technical requirements and costs of sample processing by conventional or quantitative PCR preclude their routine use in primary care facilities in resource-constrained settings. A recently developed method of Isothermal Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, coupled with lateral flow (LF) immunochromatographic strip has shown high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of RPA-LF test in two scenarios: laboratory reference center and field with community participation.

Conditions

Cutaneous Leishmaniasis (Diagnosis)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Men or women with 2 years of age and over of any ethnic group
• Ulcerated skin lesions compatible with cutaneous leishmaniasis with two or more weeks of duration
• Approval of informed consent

Exclusion Criteria

• Mucosal leishmaniasis
• Clinical presentations of cutaneous leishmaniasis different of ulcerated lesions

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

Centro Internacional de Entrenamiento e Investigaciones Médicas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, Colombia

Countries

Colombia

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Other Identifiers

222972553501

Identifier Type: OTHER

Identifier Source: secondary_id

222972553501

Identifier Type: -

Identifier Source: org_study_id