CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04500873
NCT04500873N/ACompleted

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

Centro Internacional de Entrenamiento e Investigaciones Médicas·observational·Posted Aug 5, 2020·Updated Aug 5, 2020

In Brief

An observational study for Cutaneous Leishmaniasis (Diagnosis). Completed, enrolled 128 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesColombia
CollaboratorsUniversity of Texas

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 5, 2020
Enrollment StartFeb 1, 2018
Primary CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.9 years ago