TY - JOUR
T1 - Systemic antibiotics for Pseudomonas aeruginosa infection in outpatients with non-hospitalised exacerbations of pre-existing lung diseases
T2 - a randomised clinical trial
AU - Eklöf, Josefin
AU - Alispahic, Imane Achir
AU - Armbruster, Karin
AU - Lapperre, Therese Sophie
AU - Browatzki, Andrea
AU - Overgaard, Rikke Holmen
AU - Harboe, Zitta Barrella
AU - Janner, Julie
AU - Moberg, Mia
AU - Ulrik, Charlotte Suppli
AU - Andreassen, Helle Frost
AU - Weinreich, Ulla Møller
AU - Kjærgaard, Jakob Lyngby
AU - Villadsen, Jenny
AU - Fenlev, Camilla Sund
AU - Jensen, Torben Tranborg
AU - Christensen, Christina Wellendorph
AU - Bangsborg, Jette
AU - Ostergaard, Christian
AU - Ghathian, Khaled Saoud Ali
AU - Jordan, Alexander
AU - Klausen, Tobias Wirenfeldt
AU - Nielsen, Thyge Lynghøj
AU - Wilcke, Torgny
AU - Seersholm, Niels
AU - Sivapalan, Pradeesh
AU - Jensen, Jens-Ulrik Stæhr
N1 - © 2024. The Author(s).
PY - 2024/6/6
Y1 - 2024/6/6
N2 - BACKGROUND: The effect of dual systemic antibiotic therapy against Pseudomonas aeruginosa in patients with pre-existing lung disease is unknown. To assess whether dual systemic antibiotics against P. aeruginosa in outpatients with COPD, non-cystic fibrosis (non-CF) bronchiectasis, or asthma can improve outcomes.METHODS: Multicenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365.RESULTS: The trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037.CONCLUSIONS: Use of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03262142, registration date 2017-08-25.
AB - BACKGROUND: The effect of dual systemic antibiotic therapy against Pseudomonas aeruginosa in patients with pre-existing lung disease is unknown. To assess whether dual systemic antibiotics against P. aeruginosa in outpatients with COPD, non-cystic fibrosis (non-CF) bronchiectasis, or asthma can improve outcomes.METHODS: Multicenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365.RESULTS: The trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037.CONCLUSIONS: Use of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03262142, registration date 2017-08-25.
KW - Humans
KW - Male
KW - Female
KW - Pseudomonas Infections/drug therapy
KW - Anti-Bacterial Agents/therapeutic use
KW - Aged
KW - Middle Aged
KW - Pseudomonas aeruginosa/drug effects
KW - Denmark/epidemiology
KW - Outpatients
KW - Disease Progression
KW - Treatment Outcome
KW - Hospitalization
KW - Pulmonary Disease, Chronic Obstructive/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=85195396127&partnerID=8YFLogxK
U2 - 10.1186/s12931-024-02860-9
DO - 10.1186/s12931-024-02860-9
M3 - Journal article
C2 - 38844921
SN - 1465-9921
VL - 25
SP - 236
JO - Respiratory Research
JF - Respiratory Research
IS - 1
M1 - 236
ER -