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Randomized Controlled Trial
. 2022 Sep 27;23(1):817.
doi: 10.1186/s13063-022-06720-z.

Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC): can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa-infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis, and asthma? A multicenter, randomized, controlled, open-label trial

Josefin Eklöf  1 , Imane Achir Alispahic  2 , Pradeesh Sivapalan  1   3 , Torgny Wilcke  1 , Niels Seersholm  1 , Karin Armbruster  1 , Jakob Lyngby Kjærgaard  1 , Mohamad Isam Saeed  1 , Thyge Lynghøj Nielsen  4 , Andrea Browatzki  4 , Rikke Holmen Overgaard  4 , Camilla Sund Fenlev  4 , Zitta Barella Harboe  4 , Helle Frost Andreassen  5 , Therese Sophie Lapperre  5 , Lars Pedersen  5 , Stine Johnsen  5 , Charlotte Suppli Ulrik  6 , Julie Janner  6 , Mia Moberg  6 , Maria Heidemann  6 , Ulla Møller Weinreich  7 , Roxana Vijdea  7 , Hans Linde  8 , Ingrid Titlestad  9 , Sofie Lock Johansson  9 , Flemming Schønning Rosenvinge  10 , Christian Østergaard  11 , Khaled Saoud Ali Ghathian  11 , Lise Gundersen  12 , Christina Wellendorph Christensen  12 , Jette Bangsborg  12 , Torben Tranborg Jensen  13 , Vibeke Muff Sørensen  13 , Thilde Ellingsgaard  13 , Raluca Datcu  14 , John Eugenio Coia  14 , Uffe Bodtger  3   15 , Jens Ulrik Stæhr Jensen  1   16
Affiliations
Randomized Controlled Trial

Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC): can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa-infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis, and asthma? A multicenter, randomized, controlled, open-label trial

Josefin Eklöf et al. Trials. .

Abstract

Background: Pseudomonas aeruginosa infection is seen in chronic pulmonary disease and is associated with exacerbations and poor long-term prognosis. However, evidence-based guidelines for the management and treatment of P. aeruginosa infection in chronic, non-cystic fibrosis (CF) pulmonary disease are lacking. The aim of this study is to investigate whether targeted antibiotic treatment against P. aeruginosa can reduce exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis, and asthma.

Methods: This study is an ongoing multicenter, randomized, controlled, open-label trial. A total of 150 patients with COPD, non-CF bronchiectasis or asthma, and P. aeruginosa-positive lower respiratory tract samples will be randomly assigned with a 1:1 ratio to either no antibiotic treatment or anti-pseudomonal antibiotic treatment with intravenous beta-lactam and oral ciprofloxacin for 14 days. The primary outcome, analyzed with two co-primary endpoints, is (i) time to prednisolone and/or antibiotic requiring exacerbation or death, in the primary or secondary health sector, within days 20-365 from study allocation and (ii) days alive and without exacerbation within days 20-365 from the study allocation.

Discussion: This trial will determine whether targeted antibiotics can benefit future patients with chronic, non-CF pulmonary disease and P. aeruginosa infection in terms of reduced morbidity and mortality, thus optimizing therapeutic approaches in this large group of chronic patients.

Trial registration: ClinicalTrials.gov NCT03262142 . Registered on August 25, 2017.

Keywords: Antibiotics; Asthma; Chronic obstructive pulmonary disease; Non-CF bronchiectasis; Pseudomonas aeruginosa; Randomized controlled trial.

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Conflict of interest statement

The authors declare that they have no competing interests. Pradeesh Sivapalan reports personal fees from Boehringer Ingelheim, outside the submitted work.

Figures

Fig. 1
Fig. 1
Flow diagram for the Targeted AntiBiotics for COPD trial: primary outcome overview
Fig. 2
Fig. 2
CONSORT flow diagram for the Targeted AntiBiotics for COPD trial
See this image and copyright information in PMC

References

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