The ATHENIAN Study: A clinical trial investigating the efficacy and safety of discontinuing antibiotic therapy in adult patients infected with respiratory viruses
- Conditions
- Patients with viral respiratory tract infection (influenza virus, parainfluenza virus, respiratory syncytial virus or human metapneumovirus)Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-004248-11-NO
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1.Hospitalized
2.Adults 18 year or older
3.Moderately severe disease (CRB65 = 2 at time of inclusion)
4.Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)
5.On antibiotic therapy as instituted by the receiving physician from the emergency department
6.Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320
1.Requiring ICU admission at screening
2.Requiring high-flow oxygen therapy or non-invasive ventilation at screening
3.Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)
4.Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling = 20 mg prednisolone daily for = 4 weeks, chronic immunosuppression due to solid organ transplant)
5.SARS-CoV-2 positive
6.Bacteremia
7.Urine antigen test positive for legionella
8.Any other infection necessitating antibiotic treatment
9.Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital
10.Time from initiation of antibiotic therapy to screening >48 hours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: 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. ;Primary end point(s): Early clinical response, quantified as survival with symptom improvement without receipt of rescue antibacterial therapy.;Timepoint(s) of evaluation of this end point: 120 hours after admission
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Duration of hospital admission<br>2. In-hospital mortality<br>3. 30 day mortality<br>4. Days of therapy with antibiotics<br>5. In-hospital rescue antibiotic therapy<br>6. New antibiotic therapy for assumed airway infection within 30 days after discharge<br>7. Hospital readmissions up to 30 days after discharge<br>;Timepoint(s) of evaluation of this end point: In-hospital end points - during hospital admission<br>30-day end points - at 30 days after hospital discharge