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 MobergMaria 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

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

2 Citations (Scopus)
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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.

Original languageEnglish
Article number817
JournalTrials
Volume23
Issue number1
ISSN1745-6215
DOIs
Publication statusPublished - 27 Sept 2022

Bibliographical note

© 2022. The Author(s).

Keywords

  • Anti-Bacterial Agents/adverse effects
  • Asthma/complications
  • Bronchiectasis/diagnosis
  • Ciprofloxacin/adverse effects
  • Fibrosis
  • Humans
  • Prednisolone/therapeutic use
  • Prognosis
  • Pseudomonas aeruginosa
  • Pulmonary Disease, Chronic Obstructive/drug therapy
  • beta-Lactams
  • Non-CF bronchiectasis
  • Randomized controlled trial
  • Asthma
  • Antibiotics
  • Chronic obstructive pulmonary disease

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