Duration of Antibiotic Therapy for Early (DATE) Ventilator-Associated Pneumonia (VAP) Trial: A Surgical Infection Society Multicenter Randomized Clinical Trial of 4 vs. 7 Days of Definitive Antibiotic Therapy for Early VAP
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Antibiotic Free Days
研究概览
简要总结
The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Surgical patient
- •Early VAP, defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube) (9). VAP will be defined according to local institutional protocol.
- •Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis.
- •Patients are willing to provide informed consent or their Legally Authorized Representative (LAR) is willing to provide informed consent on their behalf when the patient is unable (i.e., cognitively impaired from sedation on a ventilator)
排除标准
- •Age < 18 years
- •Prior episode of VAP for the index admission
- •VAP caused by any of the following pathogens:
- •Methicillin-resistant Staphylococcus aureus (MRSA)
- •Vancomycin-intermediate Staphylococcus aureus (VISA)
- •Pseudomonas aeruginosa
- •Vancomycin-resistant Enterococcus (VRE)
- •Acinetobacter baumanii
- •Stenotrophomonas maltophilia
- •Carbapenem-resistant Enterobacteriaceae (CRE)
- •Extended-spectrum beta lactamase-producing gram-negative bacilli
- •Causative pathogen not sensitive to choice of initial empiric antibiotic
- •Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis
- •Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring > 1 vasopressor (17)
- •Current or recent (within 30 days) use of immunosuppressive medications
- •LOS > 72 hours at a transferring facility
- •Pregnancy or lactation
- •Legal arrest or incarceration
- •Moribund state in which death is imminent
- •ECMO (Extracorporeal membrane oxygenation)
- •Extubation prior to randomization
研究组 & 干预措施
4 Days of Antibiotics Group
Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
干预措施: Standard of Care Antibiotic Therapy (Drug)
7 Days of Antibiotics Group
Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
干预措施: Standard of Care Antibiotic Therapy (Drug)
结局指标
主要结局
Antibiotic Free Days
时间窗: Up to 30 days
The number of days where participant did not require the use of antibiotics
Number of Participants With Reoccurring VAP
时间窗: Up to 21 days
VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
次要结局
- Hospital Length Of Stay(Up to 1 year)
- In-hospital Mortality(Up to 1 year)
- Number of Days of Antibiotic Exposure(Up to 30 days)
- Amount of Antibiotic Exposure(Up to 30 days)
- Clinical Improvement as Measured by the Change in Clinical Pulmonary Infection Score (CPIS) From the First Study Day to the Last(From baseline to the last study day, up to 30 days)
- Number of Participants With VAP Relapse(Up to 30 days)
- Ventilator-free Days(Up to 30 days)
- The Number of Participants With Empyema(Up to 30 days)
- The Number of Participants That Received a Tracheostomy(Up to 30 days)
- The Number of Participants With Non-pulmonary Infections(Up to 30 days)
- ICU-free Days(Up to 30 days)
研究者
Jonathan Meizoso
Assistant Professor of Surgery
University of Miami