HCAPPED I: HCAP - Pcr in Emergency Department. Early Multiplex PCR on Respiratory Samples From Patients With Pneumonia. A No-profit Observation Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- evaluate the impact of early use of multiplex PCR
研究概览
简要总结
Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit.
A pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned.
The use of syndromic molecular panels in pneumonias with risk factors for MDR (multidrug-resistant) pathogens, such as in patients with HCAP, has become common practice. However, the use of this tool is reserved for patients with severe forms of HCAP (PIRO>2, at least moderate ARDS, and respiratory failure requiring high-flow oxygen during sepsis) (30), and it is not yet standardized by international guidelines. The decision to use this tool or not is currently at the clinician's discretion and is usually reserved for the severe forms mentioned above. The study aims to determine if the early use of this tool has a real benefit on the management of antibiotic therapy for these patients in terms of therapeutic changes compared to corporate and international guidelines.
Duration of patient enrollment: 1 year. Duration of the study: 1.5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. The diagnosis must be confirmed by clinical and radiological criteria according to the IDSA guidelines, which include: New pulmonary infiltrate on chest X-ray, Evidence that the infiltrate is of infectious origin, At least two of the following three clinical signs: Fever higher than 38 °C, Leukocytosis or leukopenia, Purulent secretions.
- •Additionally, patients must meet at least one of the following criteria:
- •Need for high-flow oxygen therapy (VM35 or FiO2 >35%, Reservoir, HFNC, NIV, CPAP)
- •Intubation (IOT)
- •SOFA score ≥2 or PSI score >85 (age 75 + IR)
- •Horowitz index (PaO2/FiO2) < 200
排除标准
- •Lack of consent
- •Age under 18 or over 90
- •Pregnancy
- •Life expectancy less than 3 months
- •Hospital admission >48 hours (hospital-acquired pneumonia - HAP)
- •Rankin score ≥ 5
- •Community-acquired pneumonia (CAP)
结局指标
主要结局
evaluate the impact of early use of multiplex PCR
时间窗: perioperatively/periprocedurally
The primary objective of the study is to evaluate the impact of early use of multiplex PCR on empirical antibiotic therapy. This will be measured by considering the percentage of cases in which the use of multiplex PCR alters the therapy ('escalation' and 'de-escalation') compared to local empirical antibiotic therapy guidelines within 24 hours of hospital admission.
次要结局
- Length of Hospital Stay(up to 3 months)
- De-escalation of Antibiotic Therapy(7 days from admission)
- Escalation of Antibiotic Therapy(7 days from admission)
- Identification of HCAP Etiology(7 days from admission)
- Time to Antibiotic Escalation or De-escalation(up to 3 months)
- 30-day Mortality and Readmission(30 days from discharge)
- Need for Escalation of Supportive Therapy:(up to 3 months)
- Duration of Antibiotic Therapy:(up to 3 months)
- In-hospital Mortality(up to 3 months)
研究者
Peiman Nazerian
Principal Investigator
Azienda Ospedaliero-Universitaria Careggi