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 - Publisher Copyright: © The Author(s) 2024.

PY - 2024

Y1 - 2024

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.

U2 - 10.1186/s12931-024-02860-9

DO - 10.1186/s12931-024-02860-9

M3 - Journal article

C2 - 38844921

AN - SCOPUS:85195396127

VL - 25

JO - Respiratory Research (Print)

JF - Respiratory Research (Print)

SN - 1465-9921

IS - 1

M1 - 236

ER -