Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Number of days without antibiotics
研究概览
简要总结
Among winter respiratory viruses, influenza is the most common and therefore responsible for the highest mortality, but parainfluenza and RSV viruses have an even higher risk of mortality (1.6 to 1.9 times), this toll being paid mainly by the elderly and co-morbid population. Futhermore, SARS-Cov2 will probably become endemic and/or epidemic with the same targets of fragile patients. These viral infections are serious, however a bacterial co-infection worsens the prognosis even more: excess risk of mortality = 2.6, 95% CI [1.9-3.7].
Although rare, these co-infections are the subject of a prescription of antibiotics in more than 50% of influenza infections or other serious viral infections. Mainly due to this excess risk of mortality associated with the difficulty of diagnosing these co-infections.
Proper antibiotic use requires preventing this misuse and its harmful consequences in the short and long term at all costs. It is therefore imperative to have solid (grade A) evidence showing that antibiotic therapy in viral infections is not only futile but also potentially harmful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 65 years affiliated to a social security scheme
- •Hospitalized for a lower respiratory infection defined as:
- •the presence of 2 of the following 4 signs:
- •hyperthermia >38°C,
- •hyperleukocytosis ≥12000 or ≤4000,
- •purulent aspirations/sputum,
- •rales on pulmonary auscultation indicating parenchymal damage
- •associated with a pulmonary image (standard X-ray, CT scan or ultrasound)
- •Microbiological diagnostic sample taken within 48 hours
- •Informed consent of the patient or their representative
排除标准
- •Hospitalization planned for < 48 hours or transfer planned to another center within 7 days
- •Patient in septic shock,
- •Febrile aplasia
- •Absence of diagnostic microbiological sampling (> 48 hours after admission)
- •Moribund patient,
- •Death expected within the week
- •Inhalation proven by endoscopy or eyewitness
- •Purulent pleurisy, lung abscess, or other concomitant bacterial infection requiring antibiotic therapy.
研究组 & 干预措施
stop antibiotic
干预措施: antibiotic withdrawal (Drug)
standard of care
干预措施: Antibiotics (Drug)
结局指标
主要结局
Number of days without antibiotics
时间窗: day 30
次要结局
- number of side effects of antibiotics(day 30)
- Mortality at M1(day 30)
- martality at day 180(day 180)
- Length of hospitalization in acute care(day 30)