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

Starting soon · Not applicable

Conditions studied: Respiratory Tract Infections (RTI), Influenza-like Illness, Children

In brief

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 facts

Study ID

NCT07453914

Run by

BioMérieux

People needed

720

Starts

2026-03-01

Expected to finish

2026-09-01

Last updated by the study team

2026-03-06

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children from 60 days until less than 18 years old with signs and/or symptoms leading to suspicion of Respiratory Tract Infection (RTI) and/or Influenza-Like Illness (ILI), such as fever (Temperature greater than or equal to 37.8°C), rhinorrhea, nasal obstruction, sneezing, sore throat of pharyngeal pain, difficulties in breathing and/or cough, tachypnea, shortness of breath, apnea, croup.
• Children and his/her legal representative who provide their informed consent.
• Patients willing to provide a Nasopharyngeal Swab (NPS).

You may not qualify if…

• Any condition that, in the opinion of the investigator/nurse results in significant immune dysfunction such as known primary immunodeficiency disorder, ongoing immunosuppressive therapy, known HIV infection, active or recent oncologic disease, transplant recipients and/or chronic use of immunomodulating agents,
• Any condition that, in the opinion of the investigator/nurse, is related to severe patients requiring urgent referral who need to go on intensive care (such as patients who have a diagnosis of sepsis or septic shock,
• Known pregnancy
• Patients who refused to participate in the study and therefore declined Informed Consent Form.

Where it is running

• Hopital Robert Debré — Paris, France
• Ippokratio - General Hospital — Thessaloniki, Greece
• Södersjukhuset Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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