2024-513327-16-00招募中3 期
ASPIC - Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 15
- 主要终点
- The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment
研究概览
简要总结
The aim of this study is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of VAP
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patient is ≥18
- •Diagnosis of microbiologically confirmed of first episode of VAP
- •Initial appropriate antibiotic therapy (whether empirical or not)
- •Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure
- •Definitive diagnosis of VAP (in agreement with international guidelines) is defined by association: - Patient under MV>48 hours at the time of the microbiological sampling - New pulmonary infiltrate of which an infectious origin is strongly suspected - worsening oxygenation - Have the following clinical criteria within the 24 hours prior to the first dose of antibiotic therapy Purulent tracheal secretions And at least 1 of the following : • Documented fever (body temperature >38,3°C) • Hypothermia (body temperature <35°C) • White blood cell (WBC) count >10,000 cells/mm3 or <4,000 cells/mm3 - microbiological criteria (positive quantitative culture of a lower respiratory tract (LRT): bronchoalveolar lavage fluid (BAL) (significant threshold ≥104 colony-forming units/mL) or plugged telescopic catheter (PTC) (significant threshold ≥ 103 colony-forming units/mL) or quantitative endotracheal aspirate (ETA) distal pulmonary secretion samples (significant threshold ≥105 colony-forming units/mL)
排除标准
- •Patient under selective decontamination of the digestive tract
- •Patients requiring extracorporeal oxygen therapy (ECMO), either veno-venous or veno-arterial
- •Pregnant women
- •No health insurance coverage
- •Duration of antibiotic therapy prior to inclusion > 72h (for any reason) appropriate to the germs found in the bacterial documentation of the first episode of VAP
- •Inclusion in another interventional study concerning empirical antimicrobial strategies
- •Moribund (IGS II>80)
- •Thoracic trauma with Abbreviated Injury Scale (AIS) thorax 3
- •Severely immunocompromised patients (such as congenital immunodeficiency, neutropenia (<1leucocyte/ml or <0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below 200/mm3)
- •Patients undergoing immunosuppressive therapy or long term corticotherapy > 0.5 mg/kg
- •VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant EnterobacteriaceaeBacterial VAP occurring in the context of co-infection of COVID-19 or other viral pneumonia (confirmed by RT-PCR)
- •Patients with empyema, necrotizing and abscessed pneumonia
结局指标
主要结局
The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment
The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment
次要结局
- 12) Rate of non-interruption of antibiotic therapy despite a positive clinical cure in the intervention group only at day 28 after inclusion.
- 13) Total cumulative costs of antibiotics at day 28 and incremental cost effectiveness ratio
- 1) Rate of all-cause mortality
- 2) Rate of treatment failure
- 3) Rate of new episode of VAP
- 4) Number of antibiotic free alive-days from initiation of VAP antibiotic therapy to day 28
- 5) Global score constructed with the DOOR and RADAR. Overall clinical outcome at day 28, from most to least desirable are: 1. Survival, clinical cure 2. Survival, new pulmonary infection 3. Death
- 6) Duration of invasive MV, at day 28 after inclusion, defined as total of days under MV
- 7) Length of ICU stay at day 28 after inclusion, defined by the number of days between inclusion and ICU discharge or in-ICU death.
- 8) Rate of VAP recurrence by the intensivist at day 28
- 9) Rate of antibiotic related side effects
- 10) Rate of acquisition of MDR bacteria at day 28 defined as the identification of a MDR bacteria carriage not present at admission
- 11) Rate of death at days 28 and 90 at day 28
研究者
Dr. Arnaud FOUCRIER
Scientific
Assistance Publique Hopitaux De Paris
研究点 (15)
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