RecruitingPhase 4NCT05045612

Antibiotic Therapy in Viral Airway 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


Sponsor

University Hospital, Akershus

Enrollment

380 participants

Start Date

Jan 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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

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Interventions

OTHERStop antibiotic therapy

Stop antibiotic therapy instituted by the admitting physician


Locations(12)

Haukeland University Hospital

Bergen, Norway

Drammen Hospital, Vestre Viken Hospital Trust

Drammen, Norway

Bærum Hospital, Vestre Viken Hospital Trust

Gjettum, Norway

Sykehuset Østfold HF

Grålum, Norway

Sørlandet sykehus HF

Kristiansand, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital, Ullevål

Oslo, Norway

Telemark Hospital Trust

Skien, Norway

Stavanger University Hospital

Stavanger, Norway

University Hospital of North Norway

Tromsø, Norway

St. Olavs hospital

Trondheim, Norway

Sykehuset i Vestfold HF

Tønsberg, Norway

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NCT05045612


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