Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05045612

Antibiotic Therapy in Viral Airway Infections: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Efficacy and Safety of Discontinuing Antibiotic Therapy in Adult Patients With Respiratory Viruses

Led by University Hospital, Akershus · Updated on 2025-08-12

380

Participants Needed

12

Research Sites

130 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

Researchers are evaluating the safety and effectiveness of stopping antibiotic treatment early in adults hospitalized with respiratory viral infections. This study focuses on patients with moderately severe disease who test positive for respiratory viruses such as influenza, respiratory syncytial virus, parainfluenza virus, or human metapneumovirus. The goal is to determine if early discontinuation of antibiotics leads to similar clinical outcomes compared to continuing antibiotic therapy, aiming to reduce unnecessary antibiotic use and combat antimicrobial resistance. Participants are randomly assigned to either stop antibiotic therapy as started by their admitting physician or to continue antibiotic therapy without changes. The study monitors early clinical response at 120 hours after randomization, defined by survival with symptom improvement and no need for rescue antibiotics. Secondary assessments include mortality rates, hospital stay duration, antibiotic use, and readmission rates, all measured during hospital admission and up to 30 days after discharge. During the trial, participants undergo nasopharyngeal swab testing to confirm viral infection and are monitored closely for symptoms, survival, and antibiotic use. Researchers evaluate clinical response at 120 hours and track outcomes such as mortality, hospital stay length, and antibiotic doses until discharge and 30 days later. The study aims to gather detailed safety and efficacy data over the hospital stay and follow-up period, supporting more targeted antibiotic use in viral respiratory infections.

CONDITIONS

Brief 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 years or older
  • Moderately severe disease (CRB65 64 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 obtained and documented according to 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 (e.g., active chemotherapy, corticosteroid therapy 65 20 mg prednisolone daily for 65 4 weeks, chronic immunosuppression due to organ transplant)
  • SARS-CoV-2 positive
  • Bacteremia
  • Urine antigen test positive for legionella
  • Any other infection requiring antibiotic treatment
  • Antibiotic use for assumed airway infection within 24 hours before hospital admission
  • More than 48 hours since starting antibiotic therapy at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 120 hours after randomization

Participants are randomized to either stop antibiotic therapy or continue antibiotic therapy as prescribed by their physician to assess early clinical response.

1 baseline visit and follow-up visits during hospital admission (commonly 3-5 days)

Follow-up

Duration - 30 days after hospital discharge

Participants are monitored for outcomes including 30-day mortality, new antibiotic therapy, and readmission after hospital discharge.

1 to 2 visits depending on follow-up assessments

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

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Research Team

M

Magnus N Lyngbakken, MD PhD

O

Olav Dalgard, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Antibiotic therapy in viral airway infections (ATHENIAN): study protocol for an open labeled randomized controlled pragmatic trial to evaluate the efficacy and safety of discontinuing antibiotic therapy in adult patients infected with respiratory viruses.

Magrit Jarlsdatter Hovind, Jan Erik Berdal, Jūratė Šaltytė Benth...

https://pubmed.ncbi.nlm.nih.gov/42015169