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

NCT07453914 | Not Yet Recruiting FDA Device

• 1 other identifier: BFD-BIR-24-001
• Study Type: interventional
• Target: 720
• Locations: 3 countries
• Sites: 3

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.

Conditions

Respiratory Tract Infections (RTI); Influenza-like Illness; Children

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Component of the DOOR ranking

  From enrolment until the follow-up evaluation on day 14

• Component of the DOOR ranking

  From enrolment until the follow-up evaluation on day 14

• Component of the DOOR ranking

  From enrolment until the follow-up evaluation on day 14

• Component of the DOOR ranking

  From enrolment until the follow-up evaluation on day 14

• Component of the DOOR ranking

  From enrolment until the follow-up evaluation on day 14

Study Arms (2)

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

Diagnostic Test: SPOTFIRE R

Interventions

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

Intervention arm

Eligibility Criteria

• Age: 60 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (3)

Hopital Robert Debré

Paris, 75019, France

Location

Ippokratio - General Hospital

Thessaloniki, Greece

Location

Södersjukhuset Hospital

Stockholm, Sweden

Location

Related Publications (9)

• 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.

  PMID: 38436951 BACKGROUND

• 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.

  PMID: 37179006 BACKGROUND

• 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.

  PMID: 40512968 BACKGROUND

• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

  PMID: 497341 BACKGROUND

• 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.

  PMID: 29719423 BACKGROUND

• 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.

  PMID: 37313374 BACKGROUND

• 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.

  PMID: 36139971 BACKGROUND

• 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.

  PMID: 31102924 BACKGROUND

• 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.

  PMID: 32925706 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Solenne Robert, MS

CONTACT

+33684478785; solenne.robert@biomerieux.com

Eline Malluile, Pharm D

CONTACT

eline.malluile@biomerieux.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); FR (1); SE (1)