Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,002
- 试验地点
- 2
- 主要终点
- the risk of disease specific failure
研究概览
简要总结
The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a 7.5% higher combined failure rate, as compared to standard care practice (current guidelines for LRTI) with reduced total antibiotic (AB) use and hospitalization rate and duration, respectively.
详细描述
Background: Acute lower respiratory tract infections (LRTI), i.e. acute bronchitis and acute exacerbations of chronic obstructive pulmonary disease (AECOPD), and community-acquired pneumonia (CAP), employ important hospital resources and often unnecessary antibiotic (AB) treatment courses. We demonstrated in four intervention trials enrolling > 1200 patients that procalcitonin (PCT)-guidance markedly reduces AB prescription and duration. To ascertain the external validity, safety and potential to improve the allocation of health care resources, a non-inferiority multicenter intervention trial has to be done.
Aim: To compare a strategy based on evidence-based guidelines with PCT guided AB therapy in LRTI with respect to outcome (combined disease-specific failure rates), use of AB and hospital resources.
Design: Investigator-initiated, controlled trial with an open intervention. Patients admitted with LRTI to hospital will be included and randomized 1:1 either to standard management or to the PCT-guided prescription of AB. Randomization will be stratified by centre (the hospital) and type of LRTI (Acute bronchitis/AECOPD/CAP).
Setting: Teaching hospitals and tertiary care clinics from northwestern and central Switzerland.
Patients: 18 years or older, with LRTI of > 1 and < 28 days duration. Excluded are patients without informed consent, not fluent in German, unlikely to comply, severe immuno-suppression, terminal condition where death is expected to occur during the current hospitalization, immediate need for intensive care.
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 (Outcomes Assessor)
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
- •Patients 18 years of age or older, admitted from the community or a nursing home with acute (i.e., at least 1 day but less than 28 days) LRTI as the main diagnosis consisting of having at least two of the following:
- •new or increased respiratory signs or symptoms (i.e., cough, sputum production, dyspnea, auscultatory findings of abnormal breath sounds and rales, pleuritic chest pain) with or without inflammatory signs (core body temperature > 38.0° C, leukocyte count > 10 or < 4 x 10^9 cells L-1).
- •CAP is defined by the presence of LRTI along with a new or increased infiltrate on chest radiograph. Severity scores of CAP (pneumonia severity index [PSI] and CURB-65) will be calculated.
- •COPD is defined by post-bronchodilator spirometric criteria according to the GOLD-guidelines as a FEV1/FVC ratio below 70% and the severity categorized into mild (FEV1 <= 80% of predicted), moderate (50% >= FEV1 < 80%), severe (30% >= FEV1 < 50%) and very severe (FEV1 < 30%), respectively. Severity of acute exacerbations of COPD will be graded as proposed. Acute bronchitis is defined as LRTI in the absence of an underlying lung disease or focal chest signs and infiltrates on chest X-ray, respectively. Patients who are on admission judged as having an LRTI but have another final diagnosis, will be classified as "others".
- •Ability to understand verbal and written instructions and informed consent.
排除标准
- •Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language) and no translation (e.g. family members) available.
- •Patients with active intravenous drug use.
- •Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 10^9/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with present neutrophil count < 500 x 10^9/L and patients under chemotherapy with neutrophils 500-1000 x 10^9/L with an expected decrease to values < 500 x 10^9/L); patients with cystic fibrosis, infection with M. tuberculosis, L. pneumophila, Listeria spp. hospital stay within 14 days of inclusion.
- •Accompanying chronic (e.g. osteomyelitis), abscess (e.g. brain, pleural empyema) infection or endocarditis.
- •Terminal and very severe medical co-morbidity where death is imminent or has to be expected in the current hospitalization (e.g. due to malignancy, cardiac, renal or hepatic failure, comfort therapy).
结局指标
主要结局
the risk of disease specific failure
时间窗: within 1 month COPD
次要结局
- time to AB treatment/prescription rate, duration, rate and doses, first change, side-effects, hospitalization and discharge
- clinical stability, disease activity score, restriction days, function/health state, prediction rules and diagnostic and prognostic accuracy