Adherence to Clinical Guidelines Regarding the Duration of Antibiotic Treatment in Patients Hospitalized for Community-acquired Pneumonia With Clinical sTability. ADAPT Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Duration of antibiotic treatment
研究概览
简要总结
International and national clinical guidelines recommend short antibiotic regimens in patients with non-severe community-acquired pneumonia (CAP) who have reached clinical stability. However, adherence to these recommendations remains unclear. The goals of this quasi-experimental trial are: 1) to assess adherence to clinical guidelines in relation to the duration of antibiotic treatment in patients hospitalized for non-severe CAP who have reached clinical stability; 2) increase adherence to clinical guidelines and reduce the use of antibiotics in patients hospitalized for non-severe CAP who have achieved clinical stability after at least 5 days of antibiotic treatment.
To this end, a multicenter prospective study will be carried out over 2 years and divided into 2 phases: i) during the first year (observational phase), patients with CAP hospitalized in the participating centers will be recorded to assess objective 1; ii) to achieve objective 2, at the beginning of the second year (quasi-experimental trial) the centers will be randomized into 2 groups of hospitals, one of them a control group and the other an intervention group. The intervention will consist in automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years hospitalized for community-acquired pneumonia with a new infiltrate on chest X-ray and/or computerized tomography.
- •At least one compatible sign or symptom (fever, cough, expectoration, dyspnea, chest pain or crackles on auscultation)
- •Correctly treated with ≥ 3 days of antibiotic
排除标准
- •Intensive care unit admission during the first 5 days since hospital admission
- •Abscess or necrotizing pneumonia
- •Empyema or pleural effusion requiring drainage tube
- •Bronchiectasis
- •Cystic fibrosis
- •Active tuberculosis
- •Postobstructive pneumonia
- •Suspected bronchial aspiration
- •SARS-CoV-2 infection
- •Immunosuppression (congenital immunodeficiencies, HIV infection, solid organ transplantation, functional or anatomical asplenia, immunosuppressive treatment, active solid or haematological neoplasia [active treatment in the last 12 months], etc.)
- •Hospital acquired pneumonia
- •Concomitant extrapulmonary infection that requires antibiotic treatment for more than 5 days (eg myocarditis)
- •Confirmed diagnosis alternative to pneumonia (eg, lung cancer)
结局指标
主要结局
Duration of antibiotic treatment
时间窗: 90 days
Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).
次要结局
- Duration of antibiotic treatment after reaching clinical stability(90 days)
- Mortality(90 days)
- Adverse events related to antibiotic treatment(90 days)
- Readmission(90 days)
- Reintroduction of antibiotic treatment(90 days)
- Patients treated with an adequate duration of 5±1 days(90 days)
- Patients admitted to the ICU after the 5th day(90 days)
- Length of hospital stay(90 days)
研究者
Raúl Méndez, MD PhD
Dr.
Instituto de Investigacion Sanitaria La Fe