Proposed Procalcitonin Re-Implementation Protocol for Johns Hopkins Bayview Medical Center (JHBMC): A Stewardship Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Antibiotic Exposure
研究概览
简要总结
Antibiotics are overused in hospitals nationwide, leading to unnecessary drug costs and adverse events. Antibiotic stewardship is now a national and international priority and regulatory authorities are mandating antibiotic stewardship programs in all hospitals. Respiratory infections account for a large percentage of antibiotic overuse. Procalcitonin has been shown to help providers significantly shorten the duration of antibiotic therapy in respiratory infections. As such, this institution seeks to evaluate the impact of PCT-guided antibiotic management on antibiotic use in subjects with acute Lower Respiratory Tract Infection (LRTI) with or without sepsis. Multiple studies have been conducted in Europe and demonstrate the safety of the PCT-guided antibiotic management in pneumonia as well as sepsis. This study will apply PCT-guided therapy to those populations in an all-US study evaluating patient outcomes along with safety and efficacy.
详细描述
The study will enroll 200 patients in the Procalcitonin (PCT)-guided care cohort and 200 patients in the control cohort, using alternating 2 week time blocks until enrollment targets are reached. Patients during control or non-intervention periods will be prospectively identified and enrolled for the purposes of medical record review and follow up, but will not undergo PCT testing.
Patient Identification/ Recruitment: Intervention Periods
Patients will be identified either by the PI, research assistant, or co-investigator using an Epic system list of patients admitted to a medical service (intensive care unit (ICU) or ward) within the past 48 hours with a diagnosis of respiratory infection and receiving antibiotics for <24 hours, or via referrals from the Emergency Department and admitting teams. Candidate patients will have evidence of an acute lower respiratory tract infection (pneumonia or acute exacerbation of chronic bronchitis) as defined as follows:
o New onset within past 28 days
-At least one respiratory symptom: cough, sputum production, dyspnea, tachypnea, pleuritic chest pain, wheezing
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate patients will have evidence of an acute lower respiratory tract infection (pneumonia or acute exacerbation of chronic bronchitis) as defined as follows:
- •o NEW onset within past 28 days
- •At least one respiratory symptom: cough, sputum production, dyspnea, tachypnea, pleuritic chest pain, wheezing
- •PLUS: At least one :
- •auscultation abnormality suggestive of pneumonia (rales, ronchi, egophony)
- •OR a new consolidation on chest radiology consistent with pneumonia
- •OR at least one sign of systemic infection: fever >38.1 or WBC >10,000 or <4,000 AND provider initiating empiric antibiotics
排除标准
- •- Age <18
- •Microbiologically documented infections caused by organisms for which a prolonged duration is standard of care (i.e. Pseudomonas, Acinetobacter, Listeria, Legionella, Pneumocystis, M. tuberculosis, Non-tuberculous mycobacterium (NTM) infection, S. aureus pneumonia or cavitary pneumonia)
- •Severe infections due to viruses and parasites with a risk of bacterial translocation (hemorrhagic fever, malaria)
- •Infectious conditions requiring prolonged therapy: endocarditis, brain abscess, deep abscess
- •Antibiotics already started 24 hours prior to initial PCT value
- •Chronic localized infections (i.e. chronic osteomyelitis, mediastinitis, brain abscess)
- •Severely immunocompromised patients (HIV with CD4<200, neutropenic with absolute neutrophil count (ANC) <500, patients on immunosuppressive therapy after solid organ transplantation or those with autoimmune disease (corticosteroids allowed but no more than 20 mg/day (prednisone equivalent) for 14 days). Cystic fibrosis
- •Active IV drug abuse
- •Pregnant patients
- •Patients lacking capacity to consent
- •Patients admitted for burn injuries
- •Patients within 30 days of major intra-thoracic or intra-abdominal surgery
- •Patients receiving antibiotics for a non-respiratory infection
研究组 & 干预措施
PCT Arm
oAntibiotic management includes use of a validated PCT algorithm in addition to clinical judgment, other laboratory values, and microbiological pathogen identification. Subjects will be enrolled and data collected prospectively in 2017.
Patient records will be reviewed for outcomes data and the patients will receive a phone call for outcomes assessment at 30 days post discharge.
干预措施: PCT Arm (Device)
Control Group
Patients enrolled during the control blocks will receive antibiotics for respiratory infection at the provider's discretion in keeping with current standards of care. Patient records will be reviewed for outcomes data and the patients will receive a phone call for outcomes assessment at 30 days post discharge.
结局指标
主要结局
Antibiotic Exposure
时间窗: Hospital admission through 30 days post discharge
Total and median days of antibiotic therapy by subject compared to controls
次要结局
- Cost per case(Hospital admission through discharge date, evaluated at 3 months post discharge)
- Length of stay(Hospital admission through 30 days post discharge)
- Mortality(Hospital admission through 30 days post discharge)
- 30-day readmission(30 days post discharge)