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Antibiotic Therapy in Viral Airway Infections

RecruitingPhase 4Ages 18 Years - anyAllUniversity Hospital, Akershus
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In plain words

What the trial is, and whether it could suit you

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 manag

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📋 Eligibility rules (as published)
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
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What it tests

  • Stop antibiotic therapy
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Where

12 sites
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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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