Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP in Norway: a Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- Time in hours from receipt of respiratory specimens to receiving pathogen-directed treatment
研究概览
简要总结
Investigators will recruit patients suspected of community-acquired pneumonia at Haukeland University Hospital, Bergen, into a pragmatic randomized controlled trial to assess if provision of ultra-rapid, high-quality accurate molecular diagnostics with direct feedback to the clinician can facilitate pathogen-directed usage of antibiotics, shorten antibiotic exposure and admission time and is safe. Additionally, transcriptional and immune marker profiling of patients will guide appropriate management through a targeted focus on the individual patient's physical capacity, nutritional status and co- morbidities. The pragmatic design of this trial together with broad inclusion criteria and a straightforward intervention would make our results generalisable to other similar centres.
详细描述
The study is a pragmatic, single-blind, single-centre randomised controlled trial (RCT) where community-acquired pneumonia (CAP) patients will receive standard of care microbiological testing or standard of care microbiological testing and comprehensive ultra-rapid molecular testing (UR-MT).
Investigators will over a 3-year period (2020-2022), consecutively enroll cases of CAP admitted (~900/year) to Haukeland University Hospital (HUS, Bergen). The study will consist of representative patients admitted with CAP and thus, will potentially be generalisable to hospitalised patients with CAP in Norway. As COVID-19 cannot be distinguished clinically from other pneumonias, the study will therefore include patients with suspected CAP, including with COVID-19. Approximately 1500 CAP patients will be screened to achieve a total of 1060 (allowing for a 10% dropout rate) enrolled patients that are randomly assigned to receive standard of care microbiological testing or standard of care testing microbiological and the comprehensive ultra-rapid molecular test (UR-MT).
Inclusion criteria for the study are: adults (aged ≥18 years), with a clinical diagnosis of CAP (presence of at least two clinical criteria [new/worsening cough, new/worsening expectoration of sputum, haemoptysis, new/worsening dyspnoea, pleuritic chest pain, fever, or abnormalities on chest auscultation or percussion] or one clinical criterion and radiological evidence of CAP), requiring hospitalisation to a non-ICU ward, and with a capacity to give informed written consent or consent provided by the patient's legally authorized representative.
Exclusion criteria include: lung tumour, cystic fibrosis, a palliative approach, patients who decline to provide respiratory tract specimens, severe immunodeficiency, and hospitalization for two or more days in the last 14 days.
Based on clinical evaluation and data of admission, patients will be triaged for severity according to current risk assessment guidelines, as well as the CRB-65 score for the assessment of severity of pneumonia. Randomization of CAP patients to the two treatment arms (1:1) will be performed in blocks of size 4, 6, or, 8, occurring in random order, to ensure approximately equal allocation over the year.
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
- Single (Participant)
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
- •Adults (aged ≥18 years),
- •Clinical diagnosis of CAP (presence of at least two clinical criteria [new/worsening cough, new/worsening expectoration of sputum, haemoptysis, new/worsening dyspnoea, pleuritic chest pain, fever, or abnormalities on chest auscultation or percussion] or one clinical criterion and radiological evidence of CAP)
- •Requiring hospitalisation to a non-ICU ward
- •Capacity to give informed written consent or consent provided by the patient's legally authorized representative.
排除标准
- •Pulmonary embolism
- •Lung tumor
- •Cystic fibrosis
- •Palliative approach
- •Patients who decline to provide respiratory tract specimens
- •Severe immunodeficiency
- •Hospitalization for two or more days in the last 14 days
结局指标
主要结局
Time in hours from receipt of respiratory specimens to receiving pathogen-directed treatment
时间窗: "Up to 72 hours"
Quantitative outcome (measured in hours): time from receipt of respiratory specimens to provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant or an elapse of 48 hours, whichever event came first.
The provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant within 48 hours of receipt of respiratory samples.
时间窗: "Up to 72 hours"
Binary outcome: yes: it was provided/no: it was not provided
次要结局
- Duration of intravenous antibiotics in days("Up to 4 weeks")
- Duration of antibiotic use in days("Up to 4 weeks")
- Length of hospital stay in days("Up to 3 months")
- Proportion of 30- and 90-day and 1- and 5 year mortality("Up to 1 month, 3 months, 1 and 5 years, from admission")
- Proportion of patients receiving ≤48 h of antibiotics("Up to 1 week")
- Proportion of patients receiving intravenous antibiotics("Up to 1 week")
- Proportion of cases where the UR-MT results were used to guide treatment("Up to 1 week")
- Duration of "door-to-needle time" in hours("Up to 1 week")
- Proportion of patients receiving narrow-spectrum antibiotics within 48 hours from study inclusion("Up to 4 weeks")
- Proportion of patients receiving a single dose of antibiotics("Up to 1 week")
- Time in days to isolation or de-isolation("Up to 2 weeks")
- Proportion of 30-day readmission("Up to 30 days from discharge")