Performance of RPA-LF for Cutaneous Leishmaniasis

NCT04500873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2020-08-05

No results posted yet for this study

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.

Conditions

  • Cutaneous Leishmaniasis (Diagnosis)

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER
  • Centro Internacional de Entrenamiento e Investigaciones Médicas

    lead OTHER

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500873 on ClinicalTrials.gov