Antibiotic Therapy in Viral Airway Infections

Recruiting now · Phase 4

Conditions studied: Infectious Disease, Influenza, Respiratory Syncytial Virus (RSV), Respiratory Tract Infections

In brief

Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In the current proposal, the investigators aim to assess the efficacy and safety of early discontinuation of antibiotic therapy in adult patients infected with respiratory viruses. A general recommendation to treat all instances of community acquired pneumonia (CAP) patients with antibiotics leads to significant antibiotic overtreatment. In 2008, the US Food and Drug Administration approved the first multiplex polymerase chain reaction assay for the detection of multiple respiratory virus nucleic acids simultaneously. The wide availability of such nucleic acid amplification tests (NAAT) for rapid viral detection together with chest radiographs has the potential to define patients who can be managed without antibiotics. Akershus University Hospital is one of the largest hospitals in Norway, with a catchment area of more than 550,000 people. In 2012 to 2013, the majority of patients admitted to Akershus University Hospital with suspected CAP and a positive viral NAAT were treated with antibiotics, a prescription pattern representing antibiotic overtreatment. The investigators accordingly hypothesize that discontinuation of antibiotic therapy in patients with moderately severe disease and airway sample positive for respiratory viruses is safe and non-inferior to continuation of antibiotic therapy.

Key facts

Study ID

NCT05045612

Run by

University Hospital, Akershus

People needed

380

Starts

2022-01-13

Expected to finish

2029-11-01

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Requiring ICU admission at screening
• 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
• Time from initiation of antibiotic therapy to screening >48 hours

Where it is running

• Sykehuset i Vestfold HF — Tønsberg, Norway (enrolling)
• Drammen Hospital, Vestre Viken Hospital Trust — Drammen, Norway (enrolling)
• Akershus University Hospital — Lørenskog, Norway (enrolling)
• Oslo University Hospital, Ullevål — Oslo, Norway (enrolling)
• Stavanger University Hospital — Stavanger, Norway (enrolling)
• University Hospital of North Norway — Tromsø, Norway (enrolling)
• Sykehuset Østfold HF — Grålum, Norway (enrolling)
• Sørlandet sykehus HF — Kristiansand, Norway (enrolling)
• Bærum Hospital, Vestre Viken Hospital Trust — Gjettum, Norway
• Haukeland University Hospital — Bergen, Norway
• Telemark Hospital Trust — Skien, Norway
• St. Olavs hospital — Trondheim, Norway

Full record on ClinicalTrials.gov

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