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

ConditionsRespiratory Tract Infections (RTI)Influenza-like Illness Children

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-17

SponsorBioMérieux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

SPOTFIRE R
Diagnostic test
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

Treatment groups

720 Participants

are divided into 2 treatment groups

Group A: Control armNo intervention 0 interventions

Group B: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Evaluation of the overall clinical outcome of pediatric patients who come to the ED using a DOOR approach.

The DOOR approch is a composite endpoint created using outcomes from D0 (baseline, ED first visit of the patient) and D14 (+/- 2 days) (follow-up, done through a phone call). Patients will be ranked from most to least desirable outcome according to the following predefined criteria: * Clinical worsening and/or deterioration of the patient after D0: 1st visit e.g.: sepsis or septic shock and, re-admission, hospitalization, death (from D1 to D14) * Antibiotic prescription at D0 * Chest X-rays performed at D0 * Hospital admission at D0 * Re-consultation/additional visit (EDs or other Healthcare facilities) from D0 to D14 * ED LOS will be used as a Tie Breaker. ED LOS will be measured from patient first clinical examination to admission or discharge from ED

Time frame