Trials (Sep 2022)
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,
- Imane Achir Alispahic,
- Pradeesh Sivapalan,
- Torgny Wilcke,
- Niels Seersholm,
- Karin Armbruster,
- Jakob Lyngby Kjærgaard,
- Mohamad Isam Saeed,
- Thyge Lynghøj Nielsen,
- Andrea Browatzki,
- Rikke Holmen Overgaard,
- Camilla Sund Fenlev,
- Zitta Barella Harboe,
- Helle Frost Andreassen,
- Therese Sophie Lapperre,
- Lars Pedersen,
- Stine Johnsen,
- Charlotte Suppli Ulrik,
- Julie Janner,
- Mia Moberg,
- Maria Heidemann,
- Ulla Møller Weinreich,
- Roxana Vijdea,
- Hans Linde,
- Ingrid Titlestad,
- Sofie Lock Johansson,
- Flemming Schønning Rosenvinge,
- Christian Østergaard,
- Khaled Saoud Ali Ghathian,
- Lise Gundersen,
- Christina Wellendorph Christensen,
- Jette Bangsborg,
- Torben Tranborg Jensen,
- Vibeke Muff Sørensen,
- Thilde Ellingsgaard,
- Raluca Datcu,
- John Eugenio Coia,
- Uffe Bodtger,
- Jens Ulrik Stæhr Jensen
Affiliations
- Josefin Eklöf
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Imane Achir Alispahic
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Pradeesh Sivapalan
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Torgny Wilcke
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Niels Seersholm
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Karin Armbruster
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Jakob Lyngby Kjærgaard
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Mohamad Isam Saeed
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- Thyge Lynghøj Nielsen
- Department of Respiratory and Infectious Diseases, Frederikssund and Hillerød Hospital, University of Copenhagen
- Andrea Browatzki
- Department of Respiratory and Infectious Diseases, Frederikssund and Hillerød Hospital, University of Copenhagen
- Rikke Holmen Overgaard
- Department of Respiratory and Infectious Diseases, Frederikssund and Hillerød Hospital, University of Copenhagen
- Camilla Sund Fenlev
- Department of Respiratory and Infectious Diseases, Frederikssund and Hillerød Hospital, University of Copenhagen
- Zitta Barella Harboe
- Department of Respiratory and Infectious Diseases, Frederikssund and Hillerød Hospital, University of Copenhagen
- Helle Frost Andreassen
- Department of Respiratory Medicine, Bispebjerg Hospital, University of Copenhagen
- Therese Sophie Lapperre
- Department of Respiratory Medicine, Bispebjerg Hospital, University of Copenhagen
- Lars Pedersen
- Department of Respiratory Medicine, Bispebjerg Hospital, University of Copenhagen
- Stine Johnsen
- Department of Respiratory Medicine, Bispebjerg Hospital, University of Copenhagen
- Charlotte Suppli Ulrik
- Department of Respiratory Medicine, Amager and Hvidovre Hospital, University of Copenhagen
- Julie Janner
- Department of Respiratory Medicine, Amager and Hvidovre Hospital, University of Copenhagen
- Mia Moberg
- Department of Respiratory Medicine, Amager and Hvidovre Hospital, University of Copenhagen
- Maria Heidemann
- Department of Respiratory Medicine, Amager and Hvidovre Hospital, University of Copenhagen
- Ulla Møller Weinreich
- Department of Respiratory Medicine, Aalborg University Hospital, University of Aalborg
- Roxana Vijdea
- Department of Respiratory Medicine, Aalborg University Hospital, University of Aalborg
- Hans Linde
- Department of Clinical Microbiology, Aalborg University Hospital, University of Aalborg
- Ingrid Titlestad
- Department of Respiratory Medicine, Odense University Hospital, University of Southern Denmark
- Sofie Lock Johansson
- Department of Respiratory Medicine, Odense University Hospital, University of Southern Denmark
- Flemming Schønning Rosenvinge
- Department of Clinical Microbiology, Odense University Hospital, University of Southern Denmark
- Christian Østergaard
- Department of Clinical Microbiology, Amager and Hvidovre Hospital, University of Copenhagen
- Khaled Saoud Ali Ghathian
- Department of Clinical Microbiology, Amager and Hvidovre Hospital, University of Copenhagen
- Lise Gundersen
- Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen
- Christina Wellendorph Christensen
- Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen
- Jette Bangsborg
- Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen
- Torben Tranborg Jensen
- Department of Internal Medicine, Section of Respiratory Medicine, Hospital of South West Jutland
- Vibeke Muff Sørensen
- Department of Internal Medicine, Section of Respiratory Medicine, Hospital of South West Jutland
- Thilde Ellingsgaard
- Department of Internal Medicine, Section of Respiratory Medicine, Hospital of South West Jutland
- Raluca Datcu
- Department of Clinical Microbiology, Hospital of South West Jutland
- John Eugenio Coia
- Department of Clinical Microbiology, Hospital of South West Jutland
- Uffe Bodtger
- Department of Internal Medicine, Zealand Hospital, University of Copenhagen
- Jens Ulrik Stæhr Jensen
- Department of Internal Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital, University of Copenhagen
- DOI
- https://doi.org/10.1186/s13063-022-06720-z
- Journal volume & issue
-
Vol. 23,
no. 1
pp. 1 – 10
Abstract
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
- Chronic obstructive pulmonary disease
- Non-CF bronchiectasis
- Asthma
- Pseudomonas aeruginosa
- Antibiotics
- Randomized controlled trial
