Antibiotic Therapy in Viral Airway Infections

NCT05045612 | Recruiting Phase 4 DMC

• 2 other identifiers: 2138472021-004248-11
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Infectious Disease; Influenza; Respiratory Syncytial Virus (RSV); Respiratory Tract Infections

Keywords

pragmatic trial; antibiotic stewardship; viral respiratory tract infection

Outcome Measures

Primary Outcomes (1)

• Early clinical response

  Survival with symptom improvement without receipt of rescue antibacterial therapy

  120 hours after randomization

Secondary Outcomes (7)

• In-hospital mortality

  Untill hospital discharge (commonly 3-5 days)

• 30-day mortality

  30 days after hospital discharge

• Duration of hospital admission

  Untill hospital discharge (commonly 3-5 days)

• Antimicrobial days of therapy

  Untill hospital discharge (commonly 3-5 days)

• Rescue antibiotic therapy during hospital admission

  Untill hospital discharge (commonly 3-5 days)

Study Arms (2)

Intervention

EXPERIMENTAL

Stop antibiotic therapy as instituted by admitting physician

Other: Stop antibiotic therapy

Control

NO INTERVENTION

Continue antibiotic therapy at the discretion of the treating physician (no change in ongoing treatment)

Interventions

Stop antibiotic therapy OTHER

Stop antibiotic therapy instituted by the admitting physician

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized
• Adults 18 year or older
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator

Study Sites (12)

Haukeland University Hospital

Bergen, 5021, Norway

NOT YET RECRUITING

Drammen Hospital, Vestre Viken Hospital Trust

Drammen, 3004, Norway

RECRUITING

Bærum Hospital, Vestre Viken Hospital Trust

Gjettum, 1346, Norway

NOT YET RECRUITING

Sykehuset Østfold HF

Grålum, 1714, Norway

RECRUITING

Sørlandet sykehus HF

Kristiansand, Norway

RECRUITING

Akershus University Hospital

Lørenskog, 1478, Norway

RECRUITING

Oslo University Hospital, Ullevål

Oslo, 0424, Norway

RECRUITING

Telemark Hospital Trust

Skien, 3710, Norway

NOT YET RECRUITING

Stavanger University Hospital

Stavanger, 4068, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

St. Olavs hospital

Trondheim, 7006, Norway

NOT YET RECRUITING

Sykehuset i Vestfold HF

Tønsberg, 3103, Norway

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Influenza, Human; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Magnus N Lyngbakken, MD PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus N Lyngbakken, MD PhD

CONTACT

+4793408837; magnus.lyngbakken@medisin.uio.no

Olav Dalgard, MD PhD

CONTACT

+4792616800; olav.dalgard@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Model Details: Two-arm, open label, pragmatic randomized controlled non-inferiority stop trial

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: January 13, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (12)