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

N/ANot Yet RecruitingNCT07453914

BioMérieux720 enrolled

Overview

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.

This multicenter, prospective, randomized controlled study, aims to evaluate the impact of implementing the BIOFIRE® SPOTFIRE® R/ST Panel molecular point-of-care test in pediatric Emergency Departments (EDs) on overall patient management. The study, titled Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship (Care4Kids), will assess whether rapid molecular testing can improve clinical decision-making and optimize antimicrobial stewardship in children presenting with respiratory tract infections (RTIs) or influenza-like illness (ILI). The primary objective is to evaluate the impact of SPOTFIRE® testing performed as per standard procedure in the intervention arm compared to usual care in the control arm. Patients in the control group will be managed according to standard procedures without SPOTFIRE® testing. A follow-up call will be conducted at Day 14 to collect outcome data. The primary endpoint will be assessed using the Desirability of Outcome Ranking (DOOR) approach, which integrates multiple dimensions of patient outcomes, including clinical improvement, avoidance of unnecessary interventions, and safety. Secondary objectives include independent evaluation of each DOOR component and assessment of patient/caregiver satisfaction with the diagnostic process and overall care. The study will enroll pediatric patients aged between 60 days and 18 years who present with signs and/or symptoms of RTI or ILI and are able to provide a nasopharyngeal swab (NPS). Immunocompromised patients will be excluded. Eligible participants who provide informed consent will be randomized into either the intervention group or the control group. In the intervention group, SPOTFIRE® testing will be performed as a frontline diagnostic tool, and results will be available prior to any additional procedures or prescriptions. In the control group, patients will receive standard care without SPOTFIRE® testing. The study will be conducted across three EDs in Europ. Recruitment will begin in March 2026 and is expected to conclude in September 2026. A total of up to 680 patients will be included, with an allowance for approximately 10% loss to follow-up, resulting in a maximum sample size of 720 participants. This study is designed to provide robust evidence on the clinical utility of rapid molecular diagnostics in pediatric emergency settings and their potential role in improving patient outcomes and antimicrobial stewardship.

Eligibility

Sex: ALLMin age: 60 DaysMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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