Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05045612
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2021-09-07
Brief Title:
Antibiotic Therapy in Viral Airway Infections
Sponsor:
University Hospital Akershus
Organization:
University Hospital Akershus
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENIAN
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 550000 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
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 550000 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
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 randomization 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 randomization 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 investigators assessment of symptoms of community-acquired bacterial pneumonia and no worsening of one or more levels in other symptoms
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 randomization 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 investigators assessment of symptoms of community-acquired bacterial pneumonia and no worsening of one or more levels in other symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-004248-11 | EUDRACT_NUMBER | None | None |