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Antibiotic Therapy in Viral Airway Infections

Study acronym: ATHENIAN
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: May 2025 to May 2027 Site contacts updated at 1 of 12 sitesv14 Show 1 more changeShow less
    • Site contacts updated at 1 of 12 sites
  2. Minor Study sites: 10 to 12v13
  3. Minor Re-verified, no change to tracked fieldsv12
  4. Minor Study sites: 9 to 10v11
  5. Minor Study sites: 8 to 9v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Study sites: 7 to 8v9
  2. Minor Study sites: 5 to 7v8
  3. Minor Study sites: 1 to 5 Eligibility criteria expanded, about 10 words · Study description shortened, about 2 wordsv7 Show 2 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Primary completion date: Nov 2024 to May 2025v6
  5. Minor Re-verified, no change to tracked fieldsv5
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 2021 to Jan 13, 2022v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Jan 13, 2022
  7. Minor Secondary endpoints: 6 to 7v3 See this version in full on ClinicalTrials.gov ↗
  8. Minor Study description expanded, about 3 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05045612
Lead Sponsor University Hospital, Akershus
Collaborators: University of Oslo
Conditions Infectious Disease, Influenza, Respiratory Syncytial Virus (RSV), Respiratory Tract Infections
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov