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 - ATHENIA

Akershus University Hospital0 个研究点目标入组 400 人开始时间: 2021年9月13日最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•1.Hospitalized
•2.Adults 18 year or older
•3.Moderately severe disease (CRB65 = 2 at time of inclusion)
•4.Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)
•5.On antibiotic therapy as instituted by the receiving physician from the emergency department
•6.Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 320

•1.Requiring ICU admission at screening
•2.Requiring high-flow oxygen therapy or non-invasive ventilation at screening
•3.Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)
•4.Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling = 20 mg prednisolone daily for = 4 weeks, chronic immunosuppression due to solid organ transplant)
•5.SARS-CoV-2 positive
•6.Bacteremia
•7.Urine antigen test positive for legionella
•8.Any other infection necessitating antibiotic treatment
•9.Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital
•10.Time from initiation of antibiotic therapy to screening >48 hours

发起方

Akershus University Hospital