2023-509286-20-00招募中4 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 Hospital11 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年5月15日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 11
- 主要终点
- Early clinical response assessed at 120 hours after randomization, defined as survival with symptom improvement without receipt of rescue antibacterial therapy
研究概览
简要总结
In patients with positive airway sample for respiratory viruses, assess whether discontinuation of antibiotic therapy is safe and non-inferior to continuation of antibiotic therapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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
- •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
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Early clinical response assessed at 120 hours after randomization, defined as survival with symptom improvement without receipt of rescue antibacterial therapy
Early clinical response assessed at 120 hours after randomization, defined as survival with symptom improvement without receipt of rescue antibacterial therapy
次要结局
- In-hospital mortality
- Mortality at 30 days
- Duration of hospital admission
- Days of therapy with antibiotics
- Rescue antibiotic therapy during hospital admission
- New antibiotic therapy for presumed airway infection up to 30 days after discharge
- Hospital readmissions up to 30 days after discharge
研究者
Department of infectious diseases
Scientific
Akershus University Hospital
研究点 (11)
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