Evaluation of Strongyloidiasis in Ecuador: a fieLd Laboratory Accuracy Study

NCT04999774 | Completed FDA Device

• 1 other identifier: SCDonCalabria hospital
• Study Type: observational
• Target: 781
• Locations: 1 country
• Sites: 1

Brief Summary

the World Health Organization (WHO) has recently committed to promote the control of strongyloidiasis within 2030 targets for STH control programmes. A specific target is to establish by 2030 an efficient strongyloidiasis control programme in school aged children (SAC), envisaging ivermectin preventive chemotherapy (PC) of SAC at risk of morbidity due to strongyloidiasis. The monitoring of such ambitious PC activity strictly requires appropriate diagnostic tools, but fundamental gaps exist in this field. Indeed, until now at the moment no consensus method for the diagnosis of S. stercoralis infection is recommended and the absence of a gold standard test limits capacity for effective diagnosis, surveillance and disease control. The aim of this project is to provide fundamental information on the performance and applicability of diagnostic methods for the assessment of S. stercoralis infection to inform the forthcoming WHO global strongyloidiasis control program to be implemented as a part of the WHO 2030 disease control targets. ESTRELLA is a cross-sectional study in an area of high prevalence of strongyloidiasis (San Lorenzo, Esmeraldas, Ecuador). The study will have a school-based approach, and each enrolled SAC will be asked to supply fecal and blood samples for testing with different methods for the diagnosis of S. stercoralis infection.

Conditions

Strongyloidiasis; Strongyloides Stercoralis Infection

Outcome Measures

Primary Outcomes (2)

• Diagnostic test accuracy - primary reference standard

  The sensitivity and specificity of the serologic assays and of the rapid test will be first calculated against the results of Baermann and PCR, both considered virtually 100% specific for the study purpose. Hence, the accuracy of each test will be calculated as the proportion of positive results over all positive (for sensitivity) and negative (for specificity) samples to Baermann and/or PCR. Uncertainty will be quantified by 95% confidence intervals.

  January-February 2022

• Diagnostic test accuracy - composite reference standard

  Considering that Baerman and PCR may have lower sensitivities than the other tests, which may result in misevaluation of (too low) specificity of the other tests, the sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of all tests will be calculated also against a composite reference standard\[16\]. This will be based on a combination of the results of all tests, specifically: cases of strongyloidiasis will be identified as participants with positive PCR AND/OR Baermann AND/OR a positive serologic test plus the RDT OR two positive serologic tests. Moreover, in the latent class analysis (LCA) probabilistic models will be fitted in order to classify subjects as diseased or not diseased

  January-February 2022

Secondary Outcomes (2)

• Acceptability

  January 2022

• Feasibility of in-field deployment of each test

  January 2022

Study Arms (1)

School-age children

Each SAC will be asked to supply fecal and blood samples for testing with: * Stool microscopy * Baermann method * Real-time PCR for S. stercoralis * Lateral flow rapid test * ELISA serology (NIE/SsIR and IgG Ratti)

Diagnostic Test: Different diagnostic tests

Interventions

Different diagnostic tests DIAGNOSTIC_TEST

Each SAC will be tested with all tests

Also known as: Baermann, Stool microscopy, Strongy Detect™ IgG ELISA Kit (InBios Manufacturer), Strongyloides Ratti IgG ELISA (Bordier Manufacturer), Real-time PCR, Lateral flow test

School-age children

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

School age children attending the primary schools in the communities selected within the study area

You may qualify if:

• Children attending primary school in the selected communities

You may not qualify if:

• Refusal to participate
• Absence of written consent from parents/guardian

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead
• CECOMET (Centro de Epidemiologia Comunitaria y Medicina Tropical): collaborator
• Universidad Central del Ecuador: collaborator
• World Health Organization: collaborator

Study Sites (1)

Centro de Epidemiologia Comunitaria y Medicina Tropical (CECOMET)

Esmeraldas, Ecuador

Location

MeSH Terms

Conditions

Strongyloidiasis

Condition Hierarchy (Ancestors)

Rhabditida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Study Officials

• Angel Guevara

  Universidad Central del Ecuador

  PRINCIPAL INVESTIGATOR

• Dora Buonfrate

  IRCCS Sacro Cuore Don Calabria hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: September 6, 2021
• Primary Completion: June 11, 2022
• Study Completion: June 11, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After acceptance of pubblication of the main results of the study
• Access Criteria: The dataset will be pubblicly available

Locations

EC (1)