Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28,580
- 试验地点
- 12
- 主要终点
- Number of days of broad-spectrum antibiotic therapy
研究概览
简要总结
The purpose of this study is to reduce the exposure of broad-spectrum antimicrobials by optimizing the rapid detection of CAP pathogens and improving rates of de-escalation following negative cultures. To accomplish this, we will perform a 3-year, pragmatic, multicenter 2 X 2 factorial cluster randomized controlled trial with four arms: a) rapid diagnostic testing b) pharmacist-led de-escalation c) rapid diagnostic testing + pharmacist-led de-escalation and d) usual care
详细描述
Community-acquired pneumonia (CAP) is a leading cause of hospitalization and inpatient antimicrobial use in the United States. However, diagnostic uncertainty at the time of initial treatment and following negative cultures is associated with prolonged exposure to broad-spectrum antimicrobials. We propose a large multicenter cluster randomized controlled trial to test two approaches to reducing the use of broad-spectrum antibiotics in adult patients with CAP a) routine use of rapid diagnostic testing at the time of admission and b) pharmacist -led de-escalation after 48 hours for clinically stable patients with negative cultures.
When a patient is admitted with a diagnosis of pneumonia, it will trigger the admission order set and if the physician is in a hospital randomized to the rapid diagnostic testing arm, a CDSS-based alert will be generated in real time, and the form will append orders for viral, UAT and procalcitonin testing. For physicians at a hospital randomized to the control condition, ordering will proceed as usual (standard-of-care). A second CDSS algorithm will identify study patients who have negative culture results (blood and/or sputum) for greater than 48 hours and generate a list for the antimicrobial stewardship pharmacist, who will be a member of the study team. The alerts will be audited by the clinical pharmacist daily on weekdays at a centralized location. In clinically stable patients from hospitals randomized to the de-escalation arm, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call, Epic chat, or page. The primary outcome will be the duration of exposure to broad-spectrum antimicrobial therapy defined by the number of days of antibiotic therapy from initiation to discontinuation. Secondary outcomes will include detection of influenza/RSV, de-escalation and re-escalation to broad-spectrum antibiotics after de-escalation, total antibiotic duration, in-hospital mortality, ICU transfer after admission, healthcare-associated CDI and acute kidney injury after 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 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
- •for patient's records:
- •Men or women greater than or equal to 18 years of age
- •Admitted to a participating (i.e. enrolled and randomized) hospital
- •Admitting diagnosis of pneumonia
排除标准
- •Admission to intensive care unit within 24 hours of hospital admission
- •Comfort care measures only
- •Cystic fibrosis
- •Discharged from an acute care hospital in the past week
- •Patients not eligible for empiric therapy due to a known pathogen (any positive blood or respiratory cultures in the 72 hours prior to admission)
研究组 & 干预措施
Rapid diagnostic testing (RDT)
Rapid diagnostic testing: Eligible patients at hospitals randomized to this arm will undergo testing for viral pathogens (from November-April) and pneumococcal UAT and procalcitonin testing. If the patient is not being admitted to the ICU, and the patient has an admitting diagnosis of pneumonia, the form will append orders for viral testing, UAT and procalcitonin testing to providers in hospitals randomized to receive it.
干预措施: Rapid Diagnostic Testing (Diagnostic Test)
Pharmacist-led de-escalation
Pharmacist-led de-escalation: Another CDSS algorithm will identify CAP patients who meet study criteria and have negative culture results for > 48 hours and generate a list for the clinical pharmacist, who will be a member of the study team. The alerts will be audited by the pharmacist daily on weekdays at a centralized location. The pharmacist will attempt to determine whether each patient is clinically stable. The validated measures of clinical stability in patients with CAP are a) resolved vital sign abnormalities b) normal mental status c) ability to eat. If the patient appears stable, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call or page.
干预措施: Pharmacist-led de-escalation (Other)
Usual care (no intervention)
Usual care
Rapid diagnostic testing (RDT) and Pharmacist-led de-escalation
Rapid diagnostic testing: Eligible patients at hospitals randomized to this arm will undergo testing for viral pathogens (from November-April) and pneumococcal UAT and procalcitonin testing. If the patient is not being admitted to the ICU, and the patient has an admitting diagnosis of pneumonia, the form will append orders for viral, UAT and procalcitonin testing to providers in hospitals randomized to receive it.
Pharmacist-led de-escalation: Another CDSS algorithm will identify CAP patients who meet study criteria and have negative culture results for >48-hours and generate a list for the clinical pharmacist, who will be a member of the study team. The alerts will be audited by the pharmacist daily on weekdays at a centralized location. The pharmacist will attempt to determine whether each patient is clinically stable. If the patient appears stable, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call or page.
干预措施: Rapid Diagnostic Testing (Diagnostic Test)
Rapid diagnostic testing (RDT) and Pharmacist-led de-escalation
Rapid diagnostic testing: Eligible patients at hospitals randomized to this arm will undergo testing for viral pathogens (from November-April) and pneumococcal UAT and procalcitonin testing. If the patient is not being admitted to the ICU, and the patient has an admitting diagnosis of pneumonia, the form will append orders for viral, UAT and procalcitonin testing to providers in hospitals randomized to receive it.
Pharmacist-led de-escalation: Another CDSS algorithm will identify CAP patients who meet study criteria and have negative culture results for >48-hours and generate a list for the clinical pharmacist, who will be a member of the study team. The alerts will be audited by the pharmacist daily on weekdays at a centralized location. The pharmacist will attempt to determine whether each patient is clinically stable. If the patient appears stable, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call or page.
干预措施: Pharmacist-led de-escalation (Other)
结局指标
主要结局
Number of days of broad-spectrum antibiotic therapy
时间窗: first 21 days of admission
duration of exposure to broad-spectrum antimicrobial therapy defined by the number of days of antibiotic therapy in the first 21 days of admission as per National Healthcare Safety Network (NHSN) guidelines
次要结局
- positive pneumococcal UAT(up to 48 hours)
- de-escalation by 72 hours from admission (yes/no)(within 72 hours from admission.)
- detection of RSV (yes/no)(up to 48 hours)
- detection of viruses/atypical bacteria in the respiratory panel (yes/no)(up to 48 hours)
- 14-day mortality(up to 14 days)
- ICU transfer after admission (> 24 hours after admission)(up to 21 days)
- viral testing ordered (yes/no)(Up to 48 hours)
- detection of influenza virus (yes/no)(Up to 48 hours)
- treatment with antiviral medications(within 21 days)
- S. pneumoniae urinary antigen test (UAT) performed(up to 48 hours)
- re-escalation to broad-spectrum antibiotics after de-escalation (yes/no)(by 21 days from admission)
- treatment with anti-viral medications(up to 48 hours)
- 30-day mortality(up to 30 days)
- healthcare-associated C.difficile Infection (CDI) (yes/no)(after 72 hours of admission until discharge)
- 30-day readmission (yes/no)(up to 30 days after discharge)
- Infection with a resistant organism in the future (yes/no)(up to 6 months after discharge)
- Procalcitonin test (PCT) performed(up to 48 hours)
- empyema (yes/no)(from 48 hours to 21 days)
- total duration of any antibacterial antibiotic(up to 21 days)
- acute kidney injury after 48 hours (yes/no) after 48 hours(up to 21 days)
- total inpatient cost (from hospital's cost accounting system)(from admission to discharge or 21 days, whichever comes first)
- hospital length-of-stay (days, hours)(days from the time of admission to the time of discharge)
- Procalcitonin test (PCT) values(up to 48 hours)
- viral testing ordered (yes/no)(Up to 48 hours)
- detection of influenza virus (yes/no)(Up to 48 hours)
- detection of RSV (yes/no)(up to 48 hours)
- detection of viruses/atypical bacteria in the respiratory panel (yes/no)(up to 48 hours)
- treatment with anti-viral medications(up to 48 hours)
- treatment with antiviral medications(within 21 days)
- S. pneumoniae urinary antigen test (UAT) performed(up to 48 hours)
- positive pneumococcal UAT(up to 48 hours)
- de-escalation by 72 hours from admission (yes/no)(within 72 hours from admission.)
- re-escalation to broad-spectrum antibiotics after de-escalation (yes/no)(by 21 days from admission)
- total duration of any antibacterial antibiotic(up to 21 days)
- 14-day mortality(up to 14 days)
- 30-day mortality(up to 30 days)
- ICU transfer after admission (> 24 hours after admission)(up to 21 days)
- healthcare-associated C.difficile Infection (CDI) (yes/no)(after 72 hours of admission until discharge)
- acute kidney injury after 48 hours (yes/no) after 48 hours(up to 21 days)
- total inpatient cost (from hospital's cost accounting system)(from admission to discharge or 21 days, whichever comes first)
- hospital length-of-stay (days, hours)(days from the time of admission to the time of discharge)
- empyema (yes/no)(from 48 hours to 21 days)
- 30-day readmission (yes/no)(up to 30 days after discharge)
- Infection with a resistant organism in the future (yes/no)(up to 6 months after discharge)
研究者
Michael Rothberg
Staff Physician
The Cleveland Clinic