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临床试验/NCT02130986
NCT02130986已完成不适用

Procalcitonin Antibiotic Consensus Trial (ProACT)

University of Pittsburgh26 个研究点 分布在 1 个国家目标入组 1,664 人开始时间: 2014年11月3日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David T. Huang, MD, MPH

Associate Professor of Critcal Care and Emergency Medicine

University of Pittsburgh

研究点 (26)

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