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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form must be obtained and documented according to ICH GCP, and national/local regulations. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Stop 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