Early antibiotic treatment for Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing two different protocols. Issue 10 (29th February 2012)

• Record Type: Journal Article
• Authors: Taccetti, Giovanni; Bianchini, Elisa; Cariani, Lisa; Buzzetti, Roberto; Costantini, Diana; Trevisan, Francesca; Zavataro, Lucia; Campana, Silvia
• Is Part Of: Thorax. Volume 67:Issue 10(2012)
• Page Start: 853
• Page End: 859
• Publication Date: 2012-02-29
• Subjects: P aeruginosa -- cystic fibrosis -- early eradication treatment -- inhaled antibiotics -- aspergillus lung disease -- bacterial infection -- cystic fibrosis -- opportunist lung infections -- paediatric lung disease -- respiratory infection -- bacterial infection -- clinical epidemiology -- cystic fibrosis; Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2011-200832
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : Background: Pseudomonas aeruginosa chronic pulmonary infection is an unfavourable event in cystic fibrosis. Bacterial clearance is possible with an early antibiotic treatment upon pathogen isolation. Currently, no best practice exists for early treatment. The efficacy of two different regimens against initial P aeruginosa infection was assessed. Methods: In a randomised, open-label, parallel-group study involving 13 centres, the superiority of inhaled tobramycin/oral ciprofloxacin compared with inhaled colistin/oral ciprofloxacin (reference treatment) over 28 days was evaluated. Patients were eligible if they were older than 1 year with first or new P aeruginosa isolation. Treatments were assigned equally by centralised balanced randomisation, stratified by age and forced expiratory volume in 1 s values. The participants and those giving the intervention were not masked to arm assignments. The primary endpoint was P aeruginosa eradication, defined as three successive negative cultures in 6 months. Analysis was by intention to treat. This trial was registered with EudraCT, number 2008-006502-42. Results: 105 patients were assigned to inhaled colistin/oral ciprofloxacin (arm A) and 118 to inhaled tobramycin/oral ciprofloxacin (arm B). All patients were analysed. P aeruginosa was eradicated in 66 (62.8%) patients in arm A and in 77 (65.2%) in arm B (OR 0.90, 95% CI 0.52 to 1.55, p=0.81). Following treatment, an increase in Stenotrophomonas maltophilia was noted (OR 3.97, 95% CI 2.27 to 6.94, p=0.001) with no differences between the two arms (OR 0.89, 95% CI 0.44 to 1.78, p=0.88). Conclusions: No superiority of treatment under study was demonstrated in comparison to the reference treatment. Early eradication treatment was associated with an increase in S maltophilia .