Procalcitonin Antibiotic Consensus Trial (ProACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,664
- 试验地点
- 26
- 主要终点
- Total Antibiotic Exposure Days
研究概览
简要总结
The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI).
详细描述
There is a need for improved decision-making for antibiotic prescription in acute suspected infection. Infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. However, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance.
Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. This approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy.
Procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. Lower respiratory tract infection (LRTI) is an ideal trial population. LRTI accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.However, key questions of generalizability and safety preclude widespread application.
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
- Single (Outcomes Assessor)
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
- •≥ 18 years old
- •A primary clinical diagnosis in the ED of acute LRTI (< 28 days duration)
- •Clinician willing to consider procalcitonin in antibiotic decision-making
排除标准
- •Systemic antibiotics before ED presentation (All prophylactic antibiotic regimens, OR received >1 dose within 72 hours prior to ED presentation)
- •Current vasopressor use
- •Mechanical ventilation (via endotracheal tube)
- •Known severe immunosuppression
- •Accompanying non-respiratory infections
- •Known lung abscess or empyema
- •Chronic dialysis
- •Metastatic cancer
- •Surgery in the past 7 days (excluding minor surgery such as skin biopsy)
- •Incarcerated or homeless
- •Enrolled in ProACT in the past 30 days
研究组 & 干预措施
Procalcitonin (PCT) group
Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
干预措施: Procalcitonin level (Other)
Procalcitonin (PCT) group
Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
干预措施: Results of procalcitonin (PCT) level to treating clinician (Other)
Procalcitonin (PCT) group
Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
干预措施: Provide procalcitonin guideline to treating clinician (Other)
Procalcitonin (PCT) group
Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
干预措施: Telephone Visit (Other)
Usual Care group
Telephone Visit at Day 15 and Day 30
干预措施: Telephone Visit (Other)
结局指标
主要结局
Total Antibiotic Exposure Days
时间窗: 30 days
Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.
Number of Participants With Any Adverse Outcome
时间窗: 30 days
Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI). Number is based on the number of participants that experienced any adverse outcome.
次要结局
- Antibiotic Prescription in Emergency Department(ED)(While in the ED or before ED discharge (majority patients < 1 day))
研究者
David T. Huang, MD, MPH
Associate Professor of Critcal Care and Emergency Medicine
University of Pittsburgh
