Performance of RPA-LF for Cutaneous Leishmaniasis

NCT04500873 | Completed

• 1 other identifier: 222972553501
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis (Diagnosis)

Outcome Measures

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.

  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.

  Feb 2018 - August 2020

Secondary Outcomes (1)

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

  Feb 2018 - August 2020

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with cutaneous lesions compatible with cutaneous leishmaniasis from South west of Colombia

You may qualify if:

• 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

You may not qualify if:

• Mucosal leishmaniasis
• Clinical presentations of cutaneous leishmaniasis different of ulcerated lesions

Sponsors & Collaborators

• Centro Internacional de Entrenamiento e Investigaciones Médicas: lead
• University of Texas: collaborator

Study Sites (1)

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, 5930, Colombia

Location

Related Publications (17)

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• Cossio A, Jojoa J, Castro MDM, Castillo RM, Osorio L, Shelite TR, Gore Saravia N, Melby PC, Travi BL. Diagnostic performance of a Recombinant Polymerase Amplification Test-Lateral Flow (RPA-LF) for cutaneous leishmaniasis in an endemic setting of Colombia. PLoS Negl Trop Dis. 2021 Apr 28;15(4):e0009291. doi: 10.1371/journal.pntd.0009291. eCollection 2021 Apr.

  PMID: 33909619 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Disease

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 5, 2020
• Study Start: February 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

CO (1)