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NOT YET RECRUITING
NCT07453914
NA

Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship

Sponsor: BioMérieux

View on ClinicalTrials.gov

Summary

This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments. The research will evaluate the impact of using the BIOFIRE® SPOTFIRE® R/ST Panel, a rapid molecular point-of-care test, compared to standard care. Children aged 2 months to 18 years with symptoms of respiratory tract infection or flu-like illness will be enrolled. After consent, participants will be randomly assigned to one of two groups: * Intervention group: The SPOTFIRE test will be performed immediately to guide treatment decisions. * Control group: Patients will receive standard care without the rapid test. The study will take place in three pediatric emergency departments in France, Greece, and Sweden. Up to 720 children will participate. A follow-up phone call will be made 14 days after the visit to check recovery and satisfaction. The goal is to see whether rapid testing improves patient outcomes, reduces unnecessary treatments, and increases caregiver satisfaction.

Key Details

Gender

All

Age Range

60 Days - 17 Years

Study Type

INTERVENTIONAL

Enrollment

720

Start Date

2026-03

Completion Date

2026-09

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

SPOTFIRE R

SPOTFIRE R will be used as a frontline test and results obtained prior to any additional procedure and/or prescription performed as per standard procedure

Locations (3)

Hopital Robert Debré

Paris, France

Ippokratio - General Hospital

Thessaloniki, Greece

Södersjukhuset Hospital

Stockholm, Sweden