Stopping antibiotics for viral respiratory infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Drammen Hospital, Vestre Viken Hospital Trust
  Drammen, Norway 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
• Stavanger University Hospital
  Stavanger, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.