Actively Recruiting
Antibiotic Therapy in Viral Airway Infections
Led by University Hospital, Akershus · Updated on 2025-08-12
380
Participants Needed
12
Research Sites
407 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Akershus
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antibiotic Therapy in Viral Airway Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Haukeland University Hospital
Bergen, Norway, 5021
Not Yet Recruiting
2
Drammen Hospital, Vestre Viken Hospital Trust
Drammen, Norway, 3004
Actively Recruiting
3
Bærum Hospital, Vestre Viken Hospital Trust
Gjettum, Norway, 1346
Not Yet Recruiting
4
Sykehuset Østfold HF
Grålum, Norway, 1714
Actively Recruiting
5
Sørlandet sykehus HF
Kristiansand, Norway
Actively Recruiting
6
Akershus University Hospital
Lørenskog, Norway, 1478
Actively Recruiting
7
Oslo University Hospital, Ullevål
Oslo, Norway, 0424
Actively Recruiting
8
Telemark Hospital Trust
Skien, Norway, 3710
Not Yet Recruiting
9
Stavanger University Hospital
Stavanger, Norway, 4068
Actively Recruiting
10
University Hospital of North Norway
Tromsø, Norway, 9038
Actively Recruiting
11
St. Olavs hospital
Trondheim, Norway, 7006
Not Yet Recruiting
12
Sykehuset i Vestfold HF
Tønsberg, Norway, 3103
Actively Recruiting
Research Team
M
Magnus N Lyngbakken, MD PhD
CONTACT
O
Olav Dalgard, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here