Antibiotic Therapy in Viral Airway Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Stop antibiotic therapy
Other interventionStop antibiotic therapy instituted by the admitting physician
Treatment groups
380 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Early clinical response
Survival with symptom improvement without receipt of rescue antibacterial therapy
Time frame
120 hours after randomizationSecondary outcomes
1
In-hospital mortality
Mortality during hospital admission
Time frame
Untill hospital discharge (commonly 3-5 days)2
30-day mortality
Mortality at 30 days after hospital discharge
Time frame
30 days after hospital discharge3
Duration of hospital admission
Duration of hospital admission
Time frame
Untill hospital discharge (commonly 3-5 days)4
Antimicrobial days of therapy
Number of days on antibiotic therapy
Time frame
Untill hospital discharge (commonly 3-5 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Akershus
Lead sponsor
University of Oslo
Collaborator
Source ClinicalTrials.gov