Stopping antibiotics for viral respiratory infections
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
This study is testing if hospitalized adults with viral respiratory infections can safely stop taking antibiotics without affecting their recovery compared to those who keep taking them.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Akershus Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Bergen and 11 other locations) |
| Trial ID | NCT05045612 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of discontinuing antibiotic therapy in hospitalized adults with respiratory viral infections. It aims to determine if patients with positive airway samples for viruses can safely stop antibiotics without compromising their recovery compared to those who continue treatment. The primary outcome is the early clinical response at 120 hours post-randomization, while secondary outcomes include mortality rates and duration of hospital stays. The study leverages rapid viral detection methods to guide treatment decisions and reduce unnecessary antibiotic use.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with moderately severe respiratory viral infections who are currently on antibiotic therapy.
Not a fit: Patients requiring intensive care or exhibiting severe pneumonia symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce antibiotic overuse and combat antimicrobial resistance while ensuring patient safety.
How similar studies have performed: Other studies have shown promise in reducing antibiotic use for viral infections, but this specific approach is novel in its focus on early discontinuation based on rapid viral testing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen and 11 other locations
- Haukeland University Hospital — Bergen, Norway (Not_yet_recruiting)
- Drammen Hospital, Vestre Viken Hospital Trust — Drammen, Norway (Recruiting)
- Bærum Hospital, Vestre Viken Hospital Trust — Gjettum, Norway (Not_yet_recruiting)
- Sykehuset Østfold HF — Grålum, Norway (Recruiting)
- Sørlandet sykehus HF — Kristiansand, Norway (Recruiting)
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
- Oslo University Hospital, Ullevål — Oslo, Norway (Recruiting)
- Telemark Hospital Trust — Skien, Norway (Not_yet_recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St. Olavs hospital — Trondheim, Norway (Not_yet_recruiting)
- Sykehuset i Vestfold HF — Tønsberg, Norway (Recruiting)
Study contacts
- Principal investigator: Magnus N Lyngbakken, MD PhD — University Hospital, Akershus
- Study coordinator: Magnus N Lyngbakken, MD PhD
- Email: magnus.lyngbakken@medisin.uio.no
- Phone: +4793408837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.