Inhaled tobramycin nebulizer solution for treatment of early Pseudomonas aeruginosa infection: the ELITE study

The benefit of early antibiotic intervention in treating P. aeruginosa in patients with cystic fibrosis (CF) is increasingly acknowledged. However, the effect of different treatment periods in this early intervention is unclear. In the open-label, randomized, multicentre ELITE (EarLy Inhaled Tobramycin for Eradication) study, CF patients 6 months of age with early P. aeruginosa infection were treated twice daily with tobramycin nebulizer solution (TNS; 300mg in 5ml) for 28 or 56 days and followed up for 27 months. The primary objective was to determine the median time to recurrence of any strain of P. aeruginosa. Secondary objectives were (a) assessment of the proportion of patients free of P. aeruginosa 1 month after completion of TNS treatment and (b) a safety evaluation of TNS. All patients were initially given TNS for 28 days. Eligible patients were then randomized 1:1 either to stop TNS treatment or to receive a further 28 days of treatment. The study recruited 123 patients at 21 European CF centres; 35 patients were not randomized due to the presence of P. aeruginosa antibodies at baseline. Of the 88 randomized patients, 46 received 28 days and 42 received 56 days of treatment. Genotyping of P. aeruginosa isolates obtained at baseline and on recurrence was conducted using random amplified polymorphic DNA polymerase chain reaction and pulsed-field gel electrophoresis for similar strains. Safety monitoring assessed treatment-emergent adverse events, serum tobramycin levels, renal function, and audiometry. Study recruitment was completed in November 2005, and the last patient completed follow-up in January 2008. Final results of the study will be presented at the meeting. Supported by: Novartis Pharma AG.