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
- Conditions
- Viral respiratory tract infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-509286-20-00
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method