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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-arm, open label, pragmatic randomized controlled non-inferiority stop trial|
|Masking:||None (Open Label)|
|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|
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)
- Early clinical response [ Time Frame: 120 hours after hospital admission ]Survival with symptom improvement without receipt of rescue antibacterial therapy
- In-hospital mortality [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]Mortality during hospital admission
- 30-day mortality [ Time Frame: 30 days after hospital discharge ]Mortality at 30 days after hospital discharge
- Duration of hospital admission [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]Duration of hospital admission
- Antimicrobial days of therapy [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]Number of days on antibiotic therapy
- Rescue antibiotic therapy during hospital admission [ Time Frame: Untill hospital discharge (commonly 3-5 days) ]Rescue antibiotic therapy given to patients randomized to intervention
- New antibiotic therapy for presumed airway infection [ Time Frame: 30 days after hospital discharge ]New antibiotic therapy instituted after hospital discharge
- 30-day readmission rate [ Time Frame: 30 days after hospital discharge ]Hospital readmissions up to 30 days after hospital discharge
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
|Contact: Magnus N Lyngbakken, MD PhDemail@example.com|
|Contact: Olav Dalgard, MD PhDfirstname.lastname@example.org|
|Akershus University Hospital||Recruiting|
|Lørenskog, Norway, 1478|
|Contact: Magnus N Lyngbakken, MD PhD +4793408837 email@example.com|
|Principal Investigator:||Magnus N Lyngbakken, MD PhD||University Hospital, Akershus|