Introducing 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
Samuel Arthur Rhedin1,2, Annika Eklundh1, Malin Ryd-Rinder3
1Sachs' Children and Youth Hospital, South General Hospital, Stockholm, Sweden.
Insights
The TREND study aims to differentiate viral from bacterial pneumonia in children using biomarkers like MxA and point-of-care tests. This research will improve diagnosis and antibiotic use for pediatric community-acquired pneumonia (CAP).
Area of Science:
- Pediatric infectious diseases
- Diagnostic biomarkers
- Respiratory pathogen detection
Background:
- Distinguishing viral from bacterial community-acquired pneumonia (CAP) in children is crucial for appropriate antibiotic use.
- Current diagnostic methods lack accuracy, leading to potential overuse of antibiotics for viral infections.
Purpose of the Study:
- To improve the differential diagnosis of bacterial and viral CAP in children under 5 years old.
- To evaluate myxovirus resistance protein A (MxA) as a biomarker for viral CAP.
- To assess existing and novel point-of-care tests for respiratory pathogens.
Main Methods:
- The Trial of Respiratory infections in children for ENhanced Diagnostics (TREND) study enrolled children aged 1-59 months with clinical CAP and healthy controls.
- Blood and nasopharyngeal samples were collected for analysis of MxA, C-reactive protein, and various pathogen detection methods.
- Real-time polymerase chain reaction served as the gold standard, alongside antigen-based mariPOC respi tests and a novel recombinase polymerase amplification test.
Main Results:
- A pilot study was conducted from June to August 2017.
- Subject enrollment for the main study commenced in November 2017.
- Full study results were anticipated by the end of 2019.
Conclusions:
- The TREND study findings are expected to significantly enhance the management of pediatric CAP.
- Improved diagnostic accuracy will support more rational antibiotic prescribing practices.
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.
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