Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay - INHALE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- length of stay (LOS) in days
研究概览
简要总结
Does the use of the BIOFIRE® FILMARRAY® Pneumonia Panel plus in hospitalized patients with lower respiratory infections lead to a reduction in length of hospital stay (LOS) and customized antibiotic treatment (higher amount of specific vs empiric treatment, shorter treatment duration, less antibiotic treatment, lower incidence of side effects) compared to the standard of care?
详细描述
Lower respiratory tract infections (LRTIs) like pneumonia, exacerbations of COPD or bronchitis are caused by several viral and/or bacterial pathogens. Even in huge epidemiological studies the causative pathogen can just be detected in approximately 50% of pneumonia cases. In clinical practice the pathogen is only known in few cases, e.g. Legionella via urine antigen test. It is impossible to distinguish the triggering bacteria by clinical parameters and even accurate differentiation between bacterial and viral infections is often not possible. The same problem exists for other LRTIs.
The lack of knowledge of the causative pathogen leads to several problems:
First, clinicians tend to observe patients after treatment initiation for a longer period than probably necessary, which may lead to an increased length of hospital stay. Secondly, the antibiotic treatment has to be broad enough to cover all possible pathogens empirically. This might lead to an overuse of broad-spectrum antibiotics, an increased risk of side effects, the development of antibiotic resistance or even delayed treatment of the causative agent. Finally, antibiotics are prescribed erroneously for viral infections, which have been misinterpreted as bacterial infections by clinicians.
The BIOFIRE® FILMARRAY® Pneumonia Panel plus can help to solve these problems by identifying the causative pathogen in LRTIs within 1.5 hours. The decision of the treatment and its duration would be pathogen driven and no longer just empirically based on a lot of unknown factors.
The investigators would like to perform the following study with two groups: standard of care (control group) vs Pneumonia panel plus (intervention group). Both groups will receive the standard of care treatment but the intervention group will additionally have their sputum analyzed via the BIOFIRE® FILMARRAY® Pneumonia Panel plus.
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
- •Age ≥18 years
- •Hospitalised patients on a general ward
- •Ability to give consent
- •Ability to produce sputum
- •AND (one of the following diagnosis)
- •acute exacerabation of COPD (defined as known COPD and worsening of symptoms like dyspnea +/- wheezing +/- increased sputum purulence and the need for additional treatment)
- •Pneumonia (diagnosed via chest X-ray)
- •Lower respiratory infection (which does not belong to one of the two former diagnosis) with following symptoms:
- •At least one criterion Cough (more than usual if smoker) Dyspnea Increased sputum purulence
- •AND (at least one criterion) Respiratory rate ≥22/min Reduced oxygen saturation (<95%) (or worsening of oxygen saturation by 3% (e.g. in patients with COPD) Fever (temp >38°C) Rales/wheezing Chest pain upon breathing
排除标准
- •Other proven or suspected systemic diseases which require antibiotic treatment, like:
- •Intraabdominal infections (appendicitis, cholecystitis, diverticulitis, peritonitis)
- •C. difficile associated diarrhea (only if existing on admission otherwise it will be identified as a side effect)
- •Urinary tract infections like pyelonephritis, urosepsis, cystitis + fever (asymptomatic bacteriuria is NOT an exclusion criterion)
- •Acute bacterial skin and skin structure infections (erysipelas, abscess with systemic symptoms, diabetic foot infection, osteomyelitis)
- •Another single cause which can explain the respiratory symptoms better than an infection (acute heart failure, pulmonary embolism, hypertension induced lung edema)
- •Proven respiratory infection via another PCR based system (e.g. influenza or tuberculosis)
- •Inability to give consent
- •Inability to produce sputum
- •Moribund and palliative patients
结局指标
主要结局
length of stay (LOS) in days
时间窗: From admission to discharge or death, whichever comes first, assessed up to 12 Months
How long is the lenght of stay in days (half-days)?
次要结局
- Cost of antibiotic treatment(From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months)
- In hospital and 30-day mortality(From admission to death or 30 days after admission)
- Number of usage of specific vs empiric antibiotic treatment(From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months)
- C. difficile associated diarrhea within 30-day-follow-up(From admission to death or 30 days after admission)
- Duration of antibiotic treatment needed represented as days of treatment (DOT)(From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months)
- 30-day re-admission rate(From admission to death or 30 days after admission)
研究者
Alexander Zoufaly
PI
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