ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Days Alive Out of Hospital (Superiority Endpoint)
研究概览
简要总结
To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.
详细描述
Objective: To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antibiotic prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.
Study design: Prospective, multi-center, individually randomised, controlled trial.
Study population: Adults (≥18 years old) consulting in selected participating sites with CA-ARTI.
Study Intervention: The diagnostic intervention is rapid syndromic testing with:
- BioFire FilmArray Pneumonia Panel plus (PP): Sputum (and/or ETA or BAL sample)
- BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) presenting to the Emergency Room with an acute illness (present for 14 days or less) with cough, and with at least 1 other lower respiratory tract symptom or clinical sign at physical examination:
- •Sputum production,
- •Breathlessness,
- •Chest discomfort or chest pain,
- •Crackles,
- •Self-reported dystermia or documented fever;
- •Documented hypoxemia (adjusting definition for chronic oxygen therapy users, method of measurement) and no alternative explanation (infection, such as sinusitis; other, such as asthma).
- •Managing medical team considers:
- •to treat patient with antibiotics and/or to hospitalize patient
- •that the rapid syndromic diagnostic test result can be awaited up to a maximum of 4 hours before the decision to discharge the patient or to initiate antibiotic therapy.
排除标准
- •Development of ARTI more than 48 hours after hospital admission (hospital acquired);
- •Patients with cystic fibrosis;
- •Less than 14 days since the last episode of respiratory tract infection;
- •Pregnancy (confirmed by pregnancy test) and breastfeeding;
- •Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases or patients with short life expectancy;
- •Inability to obtain informed consent from a competent patient.
- •Based on standard of care microbiological diagnosis and thoracic imaging (when indicated):
- •Radiologically confirmed acute lobar pneumonia;
- •Known or suspected Pneumocystis jirovecii pneumonia or active tuberculosis;
- •Alternative noninfectious diagnosis that explains clinical symptoms (pulmonary embolism, alveolar hemorrhage, acute heart failure, lung cancer).
研究组 & 干预措施
Standard of Care
Standard of care testing
Intervention
Diagnostic intervention
干预措施: BioFire (Diagnostic Test)
结局指标
主要结局
Days Alive Out of Hospital (Superiority Endpoint)
时间窗: Day 1 - Day 14
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)
时间窗: Day 1 - Day 14
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Adverse Outcome (Non-inferiority Safety Endpoint)
时间窗: Day 1 - Day 30
* For initially non-admitted patients: any admission or death * For initially hospitalized patients: any readmission, ICU admission \>= 24 hours after hospitalization, or death
次要结局
- Direct Costs and Indirect Costs Within 30 Days After Enrolment.(Day 1 - Day 30)
- Microbiological Results Obtained as Standard of Care and With the Diagnostic Intervention(Day 1)
- Empirical Antibiotics Based on Antimicrobial Agent Categories(Day 1 - Day 14)
- Antibiotic Type Switches and De-escalation Based on Antimicrobial Agent Categories(Day 1 - Day 14)
- Detection of Antimicrobial Resistance (Carriage or Infection) Related to the Diagnostic Intervention Results Compared to Standard of Care and Impact on Antimicrobial Stewardship Guidelines and Prevention of Hospital Acquired Infections.(>7 days after randomisation)
- Impact on Decisions Regarding Isolation Measures Related to Test Result.(Day 1 - Day 30)
研究者
Dr. Cristina Prat
Sponsor Central Principal Investigator: Dr. C. Prat, MD, PhD, Microbiologist
UMC Utrecht