2024-515695-13-00招募中4 期
Benefits of early discontinuation of antibiotic therapy versus standard management in elderly patients hospitalized for viral infection: a multicenter, open-label, cluster-randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 7
- 主要终点
- Number of days without antibiotics at D30
研究概览
简要总结
To show that early cessation of antibiotics in viral pneumonia (presumed or confirmed) reduces antibiotic consumption at one month.
研究设计
- 分配方式
- Randomized
- 主要目的
- Standard group versus experimental group
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient hospitalized for a lower respiratory infection defined as : o the presence of 2 of the following 4 signs : o hyperthermia >38°C, o hyperleukocytosis ≥12000 or ≤4000, o aspirations/purulent sputum, o rales on pulmonary auscultation indicating parenchymal involvement o associated with a pulmonary image (standard X-ray, CT or ultrasound).
- •Microbiological diagnostic sample taken within 48 hours
排除标准
- •Planned hospitalization < 48 h or transfer to another center within 7 days
- •Patient in septic shock
- •Febrile aplasia
- •No diagnostic microbiological sample (>48h after admission)
- •Moribund patient
- •Death expected within a week
- •Inhalation proven by endoscopy or eyewitness
- •Purulent pleurisy, lung abscess, or other concomitant bacterial infection requiring antibiotic therapy.
结局指标
主要结局
Number of days without antibiotics at D30
Number of days without antibiotics at D30
次要结局
- Side effects of antibiotics: (collected in the eCRF at each occurrence) o Clostridial colitis, o venitis, o diarrhea, o nausea, o vomiting, o BMR germ colonization, o allergy, o other attributable effect: specify
- Other complications: o nosocomial infections, o complications of decubitus, o intra-hospital mortality from any cause, o confusion, o other complication attributable to hospitalization and the reason for hospitalization: specify
- Mortality at M1 and M3 or autonomy: ADL and IADL score at M1 and M3 (compared to those 15 days before hospitalization)
- Duration of hospitalization in acute care (in days)
- Number of days without antibiotics at M3
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (7)
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