Status:
RECRUITING
Antibiotic Therapy in Viral Airway Infections
Lead Sponsor:
University Hospital, Akershus
Collaborating Sponsors:
University of Oslo
Conditions:
Infectious Disease
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
In patients with positive airway sample for respiratory viruses, the investigators hypothesize that discontinuation of antibiotic therapy is safe and non-inferior to continuation of antibiotic therapy...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT05045612
Start Date
January 13 2022
End Date
November 1 2029
Last Update
August 12 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Haukeland University Hospital
Bergen, Norway, 5021
2
Drammen Hospital, Vestre Viken Hospital Trust
Drammen, Norway, 3004
3
Bærum Hospital, Vestre Viken Hospital Trust
Gjettum, Norway, 1346
4
Sykehuset Østfold HF
Grålum, Norway, 1714