DiagNostic Intervention Study of Low-dose CT and multipleX PCR on Antibiotic Treatment and Outcome of Community-Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3,555
- 试验地点
- 7
- 主要终点
- Days of therapy of broad-spectrum antibiotics
研究概览
简要总结
Rationale:
Uncertainty in the clinical and etiological diagnosis of community-acquired pneumonia (CAP) often leads to incorrect treatment and unnecessary use of broad-spectrum antibiotics. Establishing the clinical diagnosis of CAP is hampered by the suboptimal sensitivity of chest radiograph to detect pulmonary infiltrates (~70%). Establishing the etiological diagnosis is also hampered, mainly because of the inevitable diagnostic delays and low sensitivity of routine microbiological tests. There are currently no recommendations for low-dose chest computed tomography (low-dose CT) or viral and bacterial point-of-care multiplex polymerase chain reaction (PoC-PCR) in the diagnostic work-up of CAP patients, because the data supporting such an approach are lacking.
Objective: The aim of this study is to determine the added value of low-dose CT and PoC-PCR in the diagnostic workup of patients with CAP hospitalised to non-intensive care unit (ICU) wards in minimizing selective antibiotic pressure while maintaining patient safety.
Study design: Cluster-randomised controlled trial with historical control period.
Study population: Adult patients (>=18 years old) with a clinical diagnosis of CAP requiring hospitalisation to a non-ICU ward.
Intervention: Intervention arm 1: availability of PoC-PCR during the ER visit; intervention arm 2: performing low-dose CT from the ER or at least within 24 hours; control arm: standard care.
Main study parameters/endpoints: The primary effectiveness outcome is days of therapy of broad-spectrum antibiotics. The primary safety outcome, on which the sample size is calculated, is 90-day all-cause mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with performing the PoC-PCR and the radiation of the low-dose CT is of negligible risk. Nasopharyngeal swab collection causes a temporary unpleasant sensation. The low-dose CT can reveal unexpected findings which may require additional diagnostic procedures, for which the treating physician will use state-of-the-art guidelines. Treatment recommendations to de-escalate or stop antibiotic treatment may be beneficial for the individual patient by minimising exposure to antibiotics and improve targeted use of antibiotics. Final decisions are always made by the treating physician taking into account all clinical information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •aged 18 years or above;
- •working diagnosis of CAP at the emergency department with the presence of at least two clinical criteria or one clinical criterion and radiological evidence of CAP, with no other explanation for the signs and symptoms;
- •requiring hospitalisation to a non-ICU ward via the ER.
排除标准
- •Hospitalisation for two or more days in the last 14 days;
- •Residence in a long-term care facility in the last 14 days;
- •History of cystic fibrosis;
- •Severe immunodeficiency
结局指标
主要结局
Days of therapy of broad-spectrum antibiotics
时间窗: throughout hospitalization, an average of 7 days
Days of treatment with broad-spectrum antibiotics during index admission. This will include antibiotic prescriptions provided at discharge.
All-cause mortality
时间窗: 90 days
All-cause mortality within 90 days of admission.
次要结局
- time to results(throughout hospitalization, an average of 7 days)
- adverse outcomes(90 days)
- all-cause mortality(30 days)
- change in antibiotic consumption(throughout hospitalization, an average of 7 days)
- days of therapy with any antibiotic(throughout hospitalization, an average of 7 days)
- length of hospital stay(throughout hospitalization, an average of 7 days)
- time to treatment recommendations(throughout hospitalization, an average of 7 days)
- time to change in antibiotic consumption(throughout hospitalization, an average of 7 days)
研究者
MJM Bonten
Professor of molecular epidemiology of infectious diseases, head of department of medical microbiology
UMC Utrecht