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.

Page 1 of 3 (12 locations)

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