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

Who is this study for? Patients with Respiratory Tract Infections
What treatments are being studied? Stop Antibiotic Therapy
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Drammen Hospital, Vestre Viken Hospital Trust
RECRUITING
Drammen
Bærum Hospital, Vestre Viken Hospital Trust
NOT_YET_RECRUITING
Gjettum
Sykehuset Østfold HF
RECRUITING
Grålum
Sørlandet sykehus HF
RECRUITING
Kristiansand
Akershus University Hospital
RECRUITING
Lørenskog
Oslo University Hospital, Ullevål
RECRUITING
Oslo
Telemark Hospital Trust
NOT_YET_RECRUITING
Skien
Stavanger University Hospital
RECRUITING
Stavanger
Sykehuset i Vestfold HF
RECRUITING
Tønsberg
University Hospital of North Norway
RECRUITING
Tromsø
St. Olavs hospital
NOT_YET_RECRUITING
Trondheim
Contact Information
Primary
Magnus N Lyngbakken, MD PhD
magnus.lyngbakken@medisin.uio.no
+4793408837
Backup
Olav Dalgard, MD PhD
olav.dalgard@medisin.uio.no
+4792616800
Time Frame
Start Date: 2022-01-13
Estimated Completion Date: 2029-11
Participants
Target number of participants: 380
Treatments
Experimental: Intervention
Stop antibiotic therapy as instituted by admitting physician
No_intervention: Control
Continue antibiotic therapy at the discretion of the treating physician (no change in ongoing treatment)
Related Therapeutic Areas
Sponsors
Collaborators: University of Oslo
Leads: University Hospital, Akershus

This content was sourced from clinicaltrials.gov