CTIS2023-509286-20-00进行中（未招募）1 期
Antibiotic THErapy iN vIral Airway iNfections (ATHENIAN): An open labelled randomized controlled pragmatic trial to evaluate the efficacy and safety of discontinuing antibiotic therapy in adult patients infected with respiratory viruses
Akershus University Hospital0 个研究点目标入组 400 人开始时间: 2024年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Hospitalized, Adults 18 year or older, Moderately severe disease (CRB65 = 2 at time of inclusion), Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV), On antibiotic therapy as instituted by the receiving physician from the emergency department, Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.
排除标准
- •Requiring ICU admission at screening, Time from initiation of antibiotic therapy to screening >48 hours, Requiring high-flow oxygen therapy or non-invasive ventilation at screening, Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology), Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling = 20 mg prednisolone daily for = 4 weeks, chronic immunosuppression due to solid organ transplant), SARS-CoV-2 positive, Bacteremia, Urine antigen test positive for legionella, Any other infection necessitating antibiotic treatment, Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital
研究者
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