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NCT04500873: RPA-LF

Performance of RPA-LF for Cutaneous Leishmaniasis

Completed Last updated 5 August 2020
What this trial tests

trial in Cutaneous Leishmaniasis (Diagnosis) in 128 participants. Completed in 20 December 2019.

Timeline
1 February 2018
Primary endpoint
20 December 2019
20 December 2019

Quick facts

Lead sponsorCentro Internacional de Entrenamiento e Investigaciones Médicas
StatusCompleted
Study typeOBSERVATIONAL
Enrollment128
Start date1 February 2018
Primary completion20 December 2019
Estimated completion20 December 2019
Sites1 location across Colombia

Conditions studied

Sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Who can join

2 and older, any sex, with Cutaneous Leishmaniasis (Diagnosis). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Diagnostic performance of a Recombinant Polymerase Amplification Test-Lateral Flow (RPA-LF) for cutaneous leishmaniasis in an endemic setting of Colombia.
    Cossio A, Jojoa J, Castro MDM, Castillo RM, et al · · 2021 · cited 16× · PMID 33909619 · DOI 10.1371/journal.pntd.0009291

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Other Centro Internacional de Entrenamiento e Investigaciones Médicas trials

Trials by the same sponsor.

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