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Completed

NCT Number: NCT04500873

Performance of RPA-LF for Cutaneous Leishmaniasis

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.

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Key information

Conditions

Cutaneous Leishmaniasis (Diagnosis) Disease Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, 5930, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Performance of RPA-LF compared with the composite gold standard (smear, culture, histopathology, and q-PCR-18S) in two scenarios: reference laboratory and field.

    Time frame: Feb 2018 - August 2020

    Sensitivity, specificity, predictive values (positive and negative) and likelihood ratios with their corresponding 95% confidence intervals will be calculated in both scenarios. We define as true positive (TP) when at least one of the gold standard tests (smear, culture, histopathology or q-PCR-18S) and RPA-LF are positive. A patient was considered true negative (TN) when at least smear, q-PCR-18S were negative and, culture and RPA-LF also resulted in negative.

    Reference lab scenario refers to when the samples are obtained by highly trained technicians (auxiliary nurses) in urban areas localized in Tumaco in a Primary Health facility and send to the reference center in Cali to be processed. In Reference center samples are taken and processed by an expert microbiologist.

    Field refers when the samples are obtained by trained community health workers (CHW) and processed by a non-expert field technician in Tumaco in a primary health facility.

Secondary outcomes

  1. Performace of RPA-LF compared with 4 aditional reference standards in both scenarios.

    Time frame: Feb 2018 - August 2020

    Sensitivity, specificity , predictive values (positive and negative) and likelihood ratios and 95% confidence intervals will be also estimated using 4 reference tests 1)the same as the gold standard but without qPCR; 2) lesion smear microscopy and culture; 3) lesion smear microscopy read in reference lab and 4) lesion smear microscopy read in the primary health facility in both scenarios.

Sponsors and collaborators

Lead sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Other

Collaborators

  • University of Texas

Registry information

Official study title

Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia

Acronym: RPA-LF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 5, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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