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Randomized Controlled Trial
. 2024 Jun 6;25(1):236.
doi: 10.1186/s12931-024-02860-9.

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

Josefin Eklöf  1 , Imane Achir Alispahic  2 , Karin Armbruster  2 , Therese Sophie Lapperre  3   4   5 , Andrea Browatzki  6 , Rikke Holmen Overgaard  6 , Zitta Barrella Harboe  6   7 , Julie Janner  8 , Mia Moberg  8 , Charlotte Suppli Ulrik  8 , Helle Frost Andreassen  3 , Ulla Møller Weinreich  9 , Jakob Lyngby Kjærgaard  2 , Jenny Villadsen  2 , Camilla Sund Fenlev  5 , Torben Tranborg Jensen  10 , Christina Wellendorph Christensen  11 , Jette Bangsborg  11 , Christian Ostergaard  12 , Khaled Saoud Ali Ghathian  12 , Alexander Jordan  2 , Tobias Wirenfeldt Klausen  2 , Thyge Lynghøj Nielsen  6 , Torgny Wilcke  2 , Niels Seersholm  2 , Pradeesh Sivapalan  2   7 , Jens-Ulrik Stæhr Jensen  2   7
Affiliations
Randomized Controlled Trial

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

Josefin Eklöf et al. Respir Res. .

Abstract

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.

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Conflict of interest statement

The first and last author have no conflicts of interest. CSU reports personal fees from AstraZeneca, GlaxoSmithKline, TEVA, Novartis, Boehringer Ingelheim, TFF Pharmaceuticals, Berlin Chemie, Orion Pharma, Sanofi, Takeda, Pfizer and Chiesi outside of the submitted work. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram ITT intention-to-treat
Fig. 2
Fig. 2
Exacerbation and death from day 20 to 365
See this image and copyright information in PMC

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