Systemic antibiotics for Pseudomonas aeruginosa infection in outpatients with non-hospitalised exacerbations of pre-existing lung diseases: a randomised clinical trial

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2024年6月6日

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Josefin Eklöf,
Imane Achir Alispahic,
Karin Armbruster,
Therese Sophie Lapperre,
Andrea Browatzki,
Rikke Holmen Overgaard,
Zitta Barrella Harboe,
Julie Janner,
Mia Moberg,
Charlotte Suppli Ulrik,
Helle Frost Andreassen,
Ulla Møller Weinreich,
Jakob Lyngby Kjærgaard,
Jenny Villadsen,
Camilla Sund Fenlev,
Torben Tranborg Jensen,
Christina Wellendorph Christensen,
Jette Bangsborg,
Christian Ostergaard,
Khaled Saoud Ali Ghathian,
Alexander Jordan,
Tobias Wirenfeldt Klausen,
Thyge Lynghøj Nielsen,
Torgny Wilcke,
Niels Seersholm,
Pradeesh Sivapalan,
Jens-Ulrik Stæhr Jensen

摘要

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.