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Performance of RPA-LF for Cutaneous Leishmaniasis

C

Centro Internacional de Entrenamiento e Investigaciones Médicas

Status

Completed

Conditions

Cutaneous Leishmaniasis (Diagnosis)

Study type

Observational

Funder types

Other

Identifiers

NCT04500873
222972553501 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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