Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07453914

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Respiratory Tract Infections (RTI) Children Disease Infections Influenza-like Illness Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

60 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Robert Debré, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Component of the DOOR ranking

    Time frame: 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.

  2. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    The time of antibiotic and/or antiviral therapy will be collected for each patient.

  3. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    The type of antibiotic and/or antiviral therapy will be collected for each patient.

  4. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    The route of antibiotic and/or antiviral therapy will be collected for each patient.

  5. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    The duration of antibiotic and/or antiviral therapy will be collected for each patient.

  6. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    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.

  7. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    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.

  8. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    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.

  9. Component of the DOOR ranking

    Time frame: From enrolment until the follow-up evaluation on day 14

    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.

  10. Number and type of diagnostic procedures performed

    Time frame: 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.

  11. Number and type of diagnostic procedures performed

    Time frame: From enrolment until the follow-up evaluation on day 14

    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.

  12. Patient satisfaction

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eline Malluile, Pharm D

CONTACT

[email protected]

Solenne Robert, MS

CONTACT

[email protected]

+33684478785

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Registry information

Acronym: CARE4KIDS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.