Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship (CARE4KIDS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Children; Influenza-like Illness; Respiratory Tract Infections (RTI)
• Intervention / Treatment: Diagnostic test: SPOTFIRE R

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.

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Solenne Robert, MS; Phone Number: +33684478785; Email: solenne.robert@biomerieux.com
• Study Contact Backup: Name: Eline Malluile, Pharm D; Email: eline.malluile@biomerieux.com

Study Locations

• France
  • Paris, France, 75019
    • Hopital Robert Debre
• Greece
  • Thessaloniki, Greece
    • Ippokratio - General Hospital
• Sweden
  • Stockholm, Sweden
    • Södersjukhuset Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Standard of care
Experimental: Intervention arm; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrolment until the follow-up evaluation on day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component of the DOOR ranking	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.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The time of antibiotic and/or antiviral therapy will be collected for each patient.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The type of antibiotic and/or antiviral therapy will be collected for each patient.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The route of antibiotic and/or antiviral therapy will be collected for each patient.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The duration of antibiotic and/or antiviral therapy will be collected for each patient.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The proportion of patients undergoing chest X-rays at D0 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.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The rate of hospital admission at D0 and/or during the period of D0 to D14 if related to the index encounter 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.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The frequency of additional consultations for the same encounter with 14 days, assessed during the phone call. 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.	From enrolment until the follow-up evaluation on day 14
Component of the DOOR ranking	The frequency of additional visits for the same encounter with 14 days, assessed during the phone call. 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.	From enrolment until the follow-up evaluation on day 14
Number and type of diagnostic procedures performed	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.	From enrolment until the follow-up evaluation on day 14
Number and type of diagnostic procedures performed	The type 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.	From enrolment until the follow-up evaluation on day 14
Patient satisfaction	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)	From enrolment until the follow-up evaluation on day 14

Collaborators and Investigators

• Sponsor: BioMérieux

Publications and helpful links

General Publications

• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
• Schober T, Wong K, DeLisle G, Caya C, Brendish NJ, Clark TW, Dendukuri N, Doan Q, Fontela PS, Gore GC, Li P, McGeer AJ, Noel KC, Robinson JL, Suarthana E, Papenburg J. Clinical Outcomes of Rapid Respiratory Virus Testing in Emergency Departments: A Systematic Review and Meta-Analysis. JAMA Intern Med. 2024 May 1;184(5):528-536. doi: 10.1001/jamainternmed.2024.0037. Erratum In: JAMA Intern Med. 2024 Jun 1;184(6):707. doi: 10.1001/jamainternmed.2024.1450.
• Ong SWX, Petersiel N, Loewenthal MR, Daneman N, Tong SYC, Davis JS. Unlocking the DOOR-how to design, apply, analyse, and interpret desirability of outcome ranking endpoints in infectious diseases clinical trials. Clin Microbiol Infect. 2023 Aug;29(8):1024-1030. doi: 10.1016/j.cmi.2023.05.003. Epub 2023 May 12.
• Ong SWX, Mahar RK, Selman CJ, Pinto R, Davis JS, Fowler RA, Tong SYC, Daneman N. Making Sense of Hierarchical Composite End Points in Randomized Clinical Trials-A Primer for Infectious Diseases Clinicians and Researchers. Clin Infect Dis. 2025 Dec 24;81(5):e319-e329. doi: 10.1093/cid/ciaf314.
• Kaushik N, Khangulov VS, O'Hara M, Arnaout R. Reduction in laboratory turnaround time decreases emergency room length of stay. Open Access Emerg Med. 2018 Apr 20;10:37-45. doi: 10.2147/OAEM.S155988. eCollection 2018.
• Ciolino JD, Kaizer AM, Bonner LB. Guidance on interim analysis methods in clinical trials. J Clin Transl Sci. 2023 May 15;7(1):e124. doi: 10.1017/cts.2023.552. eCollection 2023.
• Brigadoi G, Gastaldi A, Moi M, Barbieri E, Rossin S, Biffi A, Cantarutti A, Giaquinto C, Da Dalt L, Dona D. Point-of-Care and Rapid Tests for the Etiological Diagnosis of Respiratory Tract Infections in Children: A Systematic Review and Meta-Analysis. Antibiotics (Basel). 2022 Sep 3;11(9):1192. doi: 10.3390/antibiotics11091192.
• Babady NE, Dunn JJ, Madej R. CLIA-waived molecular influenza testing in the emergency department and outpatient settings. J Clin Virol. 2019 Jul;116:44-48. doi: 10.1016/j.jcv.2019.05.002. Epub 2019 May 10.
• Almeida HS, Sousa M, Mascarenhas I, Russo A, Barrento M, Mendes M, Nogueira P, Trigo R. The Dynamics of Patient Visits to a Public Hospital Pediatric Emergency Department: A Time-Series Model. Pediatr Emerg Care. 2022 Jan 1;38(1):e240-e245. doi: 10.1097/PEC.0000000000002235.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: children; Pediatrics; Diagnostic; Multicenter Study; Respiratory Tract Infection; Viral Respiratory Infection; Stewardship; Pediatric Respiratory Disease; Bacterial Respiratory Infection; Point Of Care Testing; multiplex Polymerase Chain Reaction.
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Disease; Respiratory Tract Infections
• Other Study ID Numbers: BFD-BIR-24-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes