Clinical trial NCT04500873: Performance of RPA-LF for Cutaneous Leishmaniasis
Official title: Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Leishmaniasis (Diagnosis)
Lead sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2020-08-05
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with cutaneous lesions compatible with cutaneous leishmaniasis from South west of Colombia

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.

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

Primary outcomes:
measure: Performance of RPA-LF compared with the composite gold standard (smear, culture, histopathology, and q-PCR-18S) in two scenarios: reference laboratory and field.
timeFrame: Feb 2018 - August 2020
Secondary outcomes:
measure: Performace of RPA-LF compared with 4 aditional reference standards in both scenarios.
timeFrame: Feb 2018 - August 2020
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas
state: Valle
Study officials:
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