Children, Influenza-like Illness, Respiratory Tract Infections (RTI)
Conditions
Keywords
Respiratory Tract Infection, Pediatric Respiratory Disease, Viral Respiratory Infection, Bacterial Respiratory Infection, children, Pediatrics, Stewardship, Diagnostic, Multicenter Study, Point Of Care Testing, multiplex Polymerase Chain Reaction.
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSPOTFIRE 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
Sponsors
BioMérieux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the overall clinical outcome of pediatric patients who come to the ED using a DOOR approach. | From enrolment until the follow-up evaluation on day 14 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Component of the DOOR ranking | From enrolment until the follow-up evaluation on day 14 | The prescription of antimicrobial therapy initiated at D0, including both antiviral and antibiotics. Each of the DOOR components will be compared between the intervention and control group using Wilcoxon rank sum test. This DOOR component will also be analyzed using logistic regression or Poisson regression depending on data distribution. The type of antimicrobial therapy (antiviral and antibiotics), the class of antibiotics (betalactam, cephalosporins etc.), and duration of antibiotic and/or antiviral therapy will be summarized descriptively overall and separately. |
| Number and type of diagnostic procedures performed | From enrolment until the follow-up evaluation on day 14 | The number of diagnostic procedures performed, including blood tests, point-of-care Ag or molecular testing, laboratory testing (including Ag testing, molecular multiplex or single-plex) Each of the DOOR components will be compared between the intervention and control group using Wilcoxon rank sum test. This DOOR component will also be analyzed using Poisson regression. |
| Patient satisfaction | From enrolment until the follow-up evaluation on day 14 | The patient satisfaction will be assess with a survey given to the patient's parent at the ED. The survey compile 21 questions regarding : the Reception and Initial Care, Quality of medical care, Examinations performed, Communication and coordination, Overall impression and suggestions. Patient overall satisfaction score will be compared between the intervention and control group. No maetrics are plan, this is an exploratory outcomes. The Survey is adapted from: * "The medical Interview Satisfaction Scale (Miss-21)", Meakin R and John Weinman, * "Parental Stress Scale" from Child Outcomes Research Consortium (CORC) |
Countries
France, Greece, Sweden
Contacts
CONTACTSolenne Robert, MS
CONTACTEline Malluile, Pharm D
Outcome results
None listed