Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients: A Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 833
- 试验地点
- 6
- 主要终点
- Ordinal scale
研究概览
简要总结
COVID-19 is respiratory disease caused by the severe acute respiratory coronavirus 2 (SARS-CoV-2), a novel coronavirus which has spread rapidly across the world with over 149.9 million laboratory confirmed cases and over 3.1 million reported deaths since December 2019. Approximately 4-8% of hospitalized patients with COVID-19 have co-infection with bacterial pathogens however there is widespread and often broad-spectrum antibiotic use in these patients.
This is a prospective, multi-center, non-inferiority pragmatic clinical trial of antimicrobial stewardship prospective audit and feedback versus no antimicrobial stewardship intervention on physicians attending to patients with proven SARS-CoV-2 infection confirmed by nucleic acid testing in the preceding 2 weeks of hospitalization for acute COVID-19 pneumonia. Prospective audit and feedback is the real time review of antibacterial prescriptions and immediate feedback to prescribers to optimize antimicrobial prescriptions. Hospital beds will be stratified by COVID unit and critical care unit beds, and will be computer randomized in a 1:1 fashion into 2 arms (antimicrobial stewardship intervention versus no antimicrobial stewardship intervention) prior to study commencement at the participating site. Patients hospitalized to study-eligible beds will be followed for primary and secondary outcomes.
The objective of this study is to determine the effect of an antimicrobial stewardship intervention (prospective audit and feedback) on clinical outcomes in patients hospitalized with acute COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥18 years at the time of hospital admission.
- •Confirmed SARS-CoV-2 infection by nucleic acid testing in the preceding 14 days of hospital admission.
- •Admitted from the community (including continuing care facilities).
- •Admitted to a hospital bed designated in the study.
- •SpO2 ≤94% requiring supplemental oxygen or chest imaging findings compatible with COVID-19 pneumonia.
排除标准
- •The patient is enrolled in another clinical trial that involves antibacterial therapy.
- •The patient's goals of care is anticipated to be designated "total compassionate care" or palliative care within 48 hours of admission.
- •The patient's progression to death is anticipated to be imminent and inevitable within 48 hours of admission.
- •The patient was attended by any member of the research team within 30 days of enrollment.
- •The patient is transferred from another acute care center.
结局指标
主要结局
Ordinal scale
时间窗: Day 15 of hospital admission
A 7 point ordinal scale of clinical outcomes: 1. point - Not hospitalized, able to resume normal daily activities 2. points - Not hospitalized, unable to resume normal daily activities 3. points - Hospitalized, not on supplemental oxygen 4. points - Hospitalized, on supplemental oxygen 5. points - Hospitalized, on high flow oxygen therapy or non-invasive mechanical ventilation 6. points - Hospitalized, on ECMO or invasive mechanical ventilation 7. points - Death Higher scores means a worse outcome.
次要结局
- 30-day mortality(30 days)
- Antimicrobial stewardship acceptance rates(through study completion, an average of 5 days)
- Acute kidney injury(30 days)
- Length of hospital stay(through study completion, an average of 5 days)
- In-hospital mortality(through study completion, an average of 5 days)
- 30 day re-admission rate(30 days from hospital discharge)
- 30-day C. difficile associated mortality(30 days)
- Days of therapy normalized for patient-days(capped at 30 days of hospitalization)
- Length of total antimicrobial therapy normalized for patient-days(capped at 30 days of hospitalization)
- Number of antimicrobial stewardship audits(through study completion, an average of 5 days)
- Number of antimicrobial stewardship recommendations(through study completion, an average of 5 days)
- Multi-drug resistant bacteria infection rates(30 days)
- Clostridioides difficile infection rate(30 days)
- Percentage of participants with neutropenia(30 days)