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Antibiotic Therapy in Viral Airway Infections (ATHENIAN)

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ClinicalTrials.gov Identifier: NCT05045612
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Magnus Nakrem Lyngbakken, University Hospital, Akershus

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.


Condition or disease Intervention/treatment Phase
Infectious Disease Influenza Respiratory Syncytial Virus (RSV) Respiratory Tract Infections Other: Stop antibiotic therapy Phase 4

Detailed Description:

In patients with positive airway sample for respiratory viruses, the investigators hypothesize that discontinuation of antibiotic therapy is safe and non-inferior to continuation of antibiotic therapy. More specifically, the investigators hypothesize that the early clinical response assessed at 120 hours after hospital admission, defined as survival with symptom improvement without receipt of rescue antibacterial therapy, will be similar between patients who discontinue and continue antibiotic therapy. Furthermore, the investigators hypothesize that discontinuation of antibiotic therapy is associated with similar mortality rates, duration of hospital admission and reduced number of defined daily doses of antibiotics.

The primary aim is to assess whether discontinuation of antibiotic therapy in patients with positive airway sample for respiratory viruses is safe and associated with early clinical response assessed at 120 hours after hospital admission that is comparable to patients who continue antibiotic therapy.

The secondary aims are to assess whether discontinuation of antibiotic therapy in patients with positive airway sample for respiratory viruses is associated comparable (1) mortality rates, (2) duration of hospital admission, (3) defined daily doses of antibiotic therapy.

Specific objectives In patients with positive airway sample for respiratory viruses, assess the impact of discontinuing antibiotic therapy on early clinical response quantified as survival with symptom improvement without receipt of rescue antibacterial therapy. Early clinical response is defined as improvement of one or more levels relative to baseline in two or more symptoms of the investigator's assessment of symptoms of community-acquired bacterial pneumonia and no worsening of one or more levels in other symptoms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm, open label, pragmatic randomized controlled non-inferiority stop trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 13, 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Intervention
Stop antibiotic therapy as instituted by admitting physician
Other: Stop antibiotic therapy
Stop antibiotic therapy instituted by the admitting physician

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



Primary Outcome Measures :
  1. Early clinical response [ Time Frame: 120 hours after hospital admission ]
    Survival with symptom improvement without receipt of rescue antibacterial therapy


Secondary Outcome Measures :
  1. In-hospital mortality [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]
    Mortality during hospital admission

  2. 30-day mortality [ Time Frame: 30 days after hospital discharge ]
    Mortality at 30 days after hospital discharge

  3. Duration of hospital admission [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]
    Duration of hospital admission

  4. Antimicrobial days of therapy [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]
    Number of days on antibiotic therapy

  5. Rescue antibiotic therapy during hospital admission [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]
    Rescue antibiotic therapy given to patients randomized to intervention

  6. New antibiotic therapy for presumed airway infection [ Time Frame: 30 days after hospital discharge ]
    New antibiotic therapy instituted after hospital discharge

  7. 30-day readmission rate [ Time Frame: 30 days after hospital discharge ]
    Hospital readmissions up to 30 days after hospital discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05045612


Contacts
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Contact: Magnus N Lyngbakken, MD PhD +4793408837 magnus.lyngbakken@medisin.uio.no
Contact: Olav Dalgard, MD PhD +4792616800 olav.dalgard@medisin.uio.no

Locations
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Norway
Akershus University Hospital Recruiting
Lørenskog, Norway, 1478
Contact: Magnus N Lyngbakken, MD PhD    +4793408837    magnus.lyngbakken@medisin.uio.no   
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo
Investigators
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Principal Investigator: Magnus N Lyngbakken, MD PhD University Hospital, Akershus
  Study Documents (Full-Text)

Documents provided by Magnus Nakrem Lyngbakken, University Hospital, Akershus:
Study Protocol  [PDF] March 2, 2022
Statistical Analysis Plan  [PDF] June 14, 2022

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Responsible Party: Magnus Nakrem Lyngbakken, Postdoctoral fellow, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT05045612    
Other Study ID Numbers: 213847
2021-004248-11 ( EudraCT Number )
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magnus Nakrem Lyngbakken, University Hospital, Akershus:
pragmatic trial
antibiotic stewardship
viral respiratory tract infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents