DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,495
- 试验地点
- 1
- 主要终点
- Number of patients in which the empirical antibiotic therapy is de-escalated
研究概览
简要总结
DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a multicenter, international, prospective, observational cohort study, aiming to describe the rate of de-escalation as well as the associated outcome and the empirical antibiotic therapy for infections at the intensive care unit.
详细描述
Despite the consensus regarding spectrum and timing of antibiotic therapy, antimicrobial use varies across ICUs; indeed there are important variations in choice, dosing, method of administration, duration of antimicrobial therapy and de-escalation of empirical therapy. DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a multicenter, international, prospective, observational cohort study, aiming to describe the rate of de-escalation as well as the associated outcome and the empirical antibiotic therapy for infections at the intensive care unit.
Given the explorative nature of this study the required number of patients was not calculated. The investigators aim to include 2000 patients in whom empirical antibiotics are started. With an estimated de-escalation rate of 35%, an estimation to include 700 patients in whom de-escalation is performed is made which would allow for a suitable multivariable analysis.
For each participating center center data will be collected as detailed in an electronic Center Report Form. This will be completed only once per center.
For each participating center data on 4 elements will be collected: ICU-related data, microbiology laboratory practices, definition of de-escalation as used in the participating center and local de-escalation practices, background resistance levels.
This is a prospective observational study in which patients will be included in the participating centers during a 2-week period.
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
- •Age 18 years or older.
- •Patient is admitted to an ICU and has an anticipated need of ICU support of at least 48 hours.
- •Patient has a suspected or confirmed bacterial infection (community-, healthcare-, hospital- or ICU-acquired).
- •Empirical antibiotic therapy is started for this infection at any time in the ICU or no more than 24 hours prior to ICU admission. If the initial antibiotic therapy is considered inadequate and another empirical scheme is chosen at ICU admission, this will be the empirical antibiotic of the study.
- •Causative pathogen and susceptibility are unidentified at time of initiation of the antibiotic therapy (Gram staining results may be known).
- •Signed informed consent (if required by local ethics committee).
排除标准
- •Previous inclusion in this study for another infection - each patient can only be included once.
结局指标
主要结局
Number of patients in which the empirical antibiotic therapy is de-escalated
时间窗: 28 days
Included patients will be monitored for 28 days. This is the number of patients in which the empirical antibiotic therapy is de-escalated during the time of observation.
Proportion of patients with clinical cure at day 7 in de-escalated patients versus non-deescalated patients
时间窗: 7 days
This is the proportion of patients in which the infection under study is clinically cured, which is defined as: 'disappearance of all signs and symptoms related to the infection under study' in de-escalated versus non-deescalated patients.
次要结局
- Antibiotics used in empirical antimicrobial therapy in critically ill patients(28 days)
- Antibiotics used in definitive antimicrobial therapy in critically ill patients(28 days)
- Proportion of antimicrobial prescriptions in which a loading dose is used(28 days)
- Proportion of patients who died at day 28 in de-escalated patients versus non-deescalated patients(28 days)
- Proportion of patients in whom drug-resistant pathogens emerge in de-escalated patients versus non-deescalated patients(28 days)
- Proportion of appropriate empirical antibiotic therapy in critically ill patients(28 days)
- Proportion of antimicrobial prescriptions which are administered in a continuous or extended infusion(28 days)
- Duration of hospitalization on the intensive care unit in de-escalated patients versus non-deescalated patients(28 days)
- Proportion of patients with infection relapse, superinfections and subsequent infections in de-escalated patients versus non-deescalated patients(28 days)
- Duration of antimicrobial treatment for the infection under study in de-escalated patients versus non-deescalated patients(28 days)
- Number of antibiotic free days in de-escalated patients versus non-deescalated patients(28 days)