EUCTR2021-004248-11-NO
Active, Not Recruiting
Phase 1
Antibiotic THErapy iN vIral Airway iNfections (ATHENIAN): An open labelled randomized controlled pragmatic trial to evaluate the efficacy and safety of discontinuing antibiotic therapy in adult patients infected with respiratory viruses - ATHENIA
Akershus University Hospital0 sites400 target enrollmentSeptember 13, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with viral respiratory tract infection (influenza virus, parainfluenza virus, respiratory syncytial virus or human metapneumovirus)
- Sponsor
- Akershus University Hospital
- Enrollment
- 400
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 1
Antibiotic THErapy iN vIral Airway iNfections (ATHENIAN): An open labelled randomized controlled pragmatic trial to evaluate the efficacy and safety of discontinuing antibiotic therapy in adult patients infected with respiratory virusesViral respiratory tract infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]CTIS2023-509286-20-00Akershus University Hospital400
Active, Not Recruiting
Phase 1
ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONSCommunity acquired pneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2019-001873-10-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS310
Recruiting
Phase 4
Antibiotic Therapy in Viral Airway InfectionsInfectious DiseaseInfluenzaRespiratory Syncytial Virus (RSV)Respiratory Tract InfectionsNCT05045612University Hospital, Akershus380
Completed
Phase 2
Antibiotics in Patients With Acute Respiratory Tract Infection With Procalcitonin as ParameterRespiratory Tract InfectionNCT00688610Hannover Medical School571
Active, Not Recruiting
Phase 1
Antibiotics for chest infections in children consulting with the GPRespiratory tract infections in children aged between 6 months and 12 yearsMedDRA version: 20.1Level: LLTClassification code 10066740Term: Acute respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10024968Term: Lower respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2015-002455-97-GBniversity of Southampton938