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