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
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Brief Title
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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
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
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
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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.
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...