Respiratory Tract Infections (RTI)CARE4KIDSNCT07453914
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
A study testing SPOTFIRE R in people with Respiratory Tract Infections (RTI) and Influenza-like Illness, run by BioMérieux at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 days to 17 years
- Conditions the study is for
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- What is being tested?
- SPOTFIRE R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2026to Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Eline Malluile, Pharm D contact
3 sites in 3 countries
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- SPOTFIRE R
- 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.
- Medical subject headings
- Respiratory Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOTFIRE RDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Standard of care |
| Intervention arm | Experimental | 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 Receives: Diagnostic Test: SPOTFIRE R |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrolment until the follow-up evaluation on day 14
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: From enrolment until the follow-up evaluation on day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract Infections (RTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453914
- Sponsor's protocol ID
- BFD-BIR-24-001
- Acronym
- CARE4KIDS
- Status last verified
- Jan 2026
- First submitted
- 19 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38436951Ong 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.
PubMed 37179006Ong 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.
PubMed 40512968O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
PubMed 497341Kaushik 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.
PubMed 29719423Ciolino 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.
PubMed 37313374Brigadoi 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.
PubMed 36139971Babady 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.
PubMed 31102924Almeida 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.
PubMed 32925706