Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioMérieux
- 入组人数
- 720
- 试验地点
- 3
- 主要终点
- Evaluation of the overall clinical outcome of pediatric patients who come to the ED using a DOOR approach.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Control arm
Standard of care
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
干预措施: SPOTFIRE R (Diagnostic Test)
结局指标
主要结局
Evaluation of the overall clinical outcome of pediatric patients who come to the ED using a DOOR approach.
时间窗: 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
次要结局
- Component of the DOOR ranking(From enrolment until the follow-up evaluation on day 14)
- Number and type of diagnostic procedures performed(From enrolment until the follow-up evaluation on day 14)
- Patient satisfaction(From enrolment until the follow-up evaluation on day 14)