Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05045612

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

1
2
3
+1

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

Loading map...

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