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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Evaluation of the overall clinical outcome of pediatric patients who come to the ED using a DOOR approach. [Срок оценки: From enrolment until the follow-up evaluation on day 14]

Вторичные конечные точки (12)

• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Component of the DOOR ranking [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Number and type of diagnostic procedures performed [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Number and type of diagnostic procedures performed [Срок оценки: From enrolment until the follow-up evaluation on day 14]
• Patient satisfaction [Срок оценки: From enrolment until the follow-up evaluation on day 14]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Hopital Robert Debré — Paris

Греция · 1 центр

• Ippokratio - General Hospital — Thessaloniki

Швеция · 1 центр

• Södersjukhuset Hospital — Stockholm

Публикации

• 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
• 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
• 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
• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. PMID 497341
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07453914 · BFD-BIR-24-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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