CTIS2023-503645-63-00招募中1 期
Amoxicillin alone versus amoxicillin/clavulanate for community-acquired pneumonia in patients aged 65 years or older, and hospitalized in a non-intensive care unit ward: a non-inferiority randomized controlled trial _ CAPTAIN - RC20_0015
Centre Hospitalier Universitaire De Nantes0 个研究点目标入组 326 人开始时间: 2023年9月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 326
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 65+（—）
- 性别
- All
入选标准
- •Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients, Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature > 38°C) or hypothermia (< 36°C)) and radiological evidence of a new infiltrate confirming pneumonia, Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person), Patient understanding oral and written French, Patients should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by a medical staff belonging to the investigational site
排除标准
- •Patient requiring ICU admission, Subjects with clinical or epidemiological environment leading to suspect a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility), Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the respiratory tract, Suspicion of aspiration pneumonia, Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission), History of bacterial pneumonia less than 1 month prior to study inclusion, History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid, History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics, Subject without health insurance, Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation), Patient under judicial protection, Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, or chest computed tomography (CT) scan), Administration of any antibiotic treatment for more than 24 hours before inclusion, Participation to another interventional study and having an exclusion period that is still in force during the screening phase or expected participation to another interventional study during participation to the CAPTAIN study, Estimated Glomerular Filtration Rate < 30 ml/min, Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3), Exacerbation of chronic obstructive pulmonary disease, Life-threatening presentation expected to lead to possible imminent death, Suspected atypical bacteria requiring combined antibiotics therapy, Legionella suspected
研究者
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