Open AccessIntroducing a New Algorithm for Classification of Etiology in Studies on Pediatric Pneumonia: Protocol for the Trial of Respiratory Infections in Children for Enhanced Diagnostics Study
Author(s) -
Samuel Rhedin,
Annika Eklundh,
Malin Ryd Rinder,
Pontus Nauclér,
Andreas Mårtensson,
Jesper Gantelius,
Ingela Zenk,
Helene Andersson-Svahn,
Susanybond,
Reza Rasti,
Magnus Lindh,
Maria Andersson,
Ville Peltola,
Matti Waris,
Tobias Alfvén
Publication year - 2019
Publication title -
jmir research protocols
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.378
H-Index - 9
ISSN - 1929-0748
DOI - 10.2196/12705
Subject(s) - pneumonia , medicine , etiology , intensive care medicine , protocol (science) , antibiotics , clinical trial , respiratory tract infections , pediatrics , respiratory system , alternative medicine , pathology , biology , microbiology and biotechnology
Background There is a need to better distinguish viral infections from antibiotic-requiring bacterial infections in children presenting with clinical community-acquired pneumonia (CAP) to assist health care workers in decision making and to improve the rational use of antibiotics. Objective The overall aim of the Trial of Respiratory infections in children for ENhanced Diagnostics (TREND) study is to improve the differential diagnosis of bacterial and viral etiologies in children aged below 5 years with clinical CAP, by evaluating myxovirus resistance protein A (MxA) as a biomarker for viral CAP and by evaluating an existing (multianalyte point-of-care antigen detection test system [mariPOC respi] ArcDia International Oy Ltd.) and a potential future point-of-care test for respiratory pathogens. Methods Children aged 1 to 59 months with clinical CAP as well as healthy, hospital-based, asymptomatic controls will be included at a pediatric emergency hospital in Stockholm, Sweden. Blood (analyzed for MxA and C-reactive protein) and nasopharyngeal samples (analyzed with real-time polymerase chain reaction as the gold standard and antigen-based mariPOC respi test as well as saved for future analyses of a novel recombinase polymerase amplification–based point-of-care test for respiratory pathogens) will be collected. A newly developed algorithm for the classification of CAP etiology will be used as the reference standard. Results A pilot study was performed from June to August 2017. The enrollment of study subjects started in November 2017. Results are expected by the end of 2019. Conclusions The findings from the TREND study can be an important step to improve the management of children with clinical CAP. International Registered Report Identifier (IRRID) DERR1-10.2196/12705