Rationale Antibiotic therapy for early Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) is effective, but the optimal therapeutic regimen and duration for early treatment remains unclear. The EarLy Inhaled Tobramycin for Eradication (ELITE) study was designed to assess the efficacy and safety of two regimens (28 and 56 days) of tobramycin inhalation solution (TIS) 300 mg/5 ml twice daily for the treatment of early onset P aeruginosa infection in patients with CF.
Methods In this open-label randomised multicentre study, patients with CF (aged ≥6 months) with early P aeruginosa infection were treated for 28 days with TIS twice daily administered by the PARI LC PLUS (PARI GmbH, Starnberg, Germany) jet nebuliser. After 28 days, patients were randomised 1:1 to either stop TIS (n=45) or to receive a further 28 days of TIS (n=43). The primary endpoint was the median time to recurrence of P aeruginosa (any strain). Secondary endpoints included the proportion of patients free of P aeruginosa infection 1 month after cessation of therapy and safety assessments.
Results The median time to recurrence of P aeruginosa (any strain) was similar between the two groups. In total, 93% and 92% of the patients were free of P aeruginosa infection 1 month after the end of treatment and 66% and 69% remained free at the final visit in the 28-day and 56-day groups, respectively. TIS was well tolerated.
Conclusions Treatment with TIS for 28 days is an effective and well tolerated therapy for early P aeruginosa infection in patients with CF.
Trial registration number NCT00391976.
- Cystic fibrosis
- Pseudomonas aeruginosa
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ELITE study collaborators: Germany: Professor Ratjen (Essen), Dr Ballmann (Hannover), Professor Dockter (Hamburg), Dr Mainz (Jena), Dr Nusslein (Bochum), Dr Posselt (Frankfurt), Dr Rietschel (Cologne), Dr Leichsenring (Ulm), Dr Staab (Berlin); France: Dr Munck, Dr Gerardin, Dr Delaisi (Paris-Debre), Dr Fayon (Bordeaux), Professor Ginies (Angers), Dr Le Bourgeois (Paris-Necker), Professor Marguet (Rouen), Professor Roussey (Rennes); The Netherlands: Dr Tiddens (Rotterdam), Dr Bert Arets (Utrecht); UK: Dr Spencer (Newcastle upon Tyne), Dr Weller (Birmingham); Spain: Dr Cobos (Barcelona); Austria: Professor Eichler (Vienna).
↵* ELITE investigators are listed as collaborators at the end of the manuscript.
Funding Chiron was involved in the initiation and design of the study. Novartis Pharma AG, Basel, Switzerland, subsequently assumed sponsor's responsibility and was involved in the collection, analysis and interpretation of data.
Competing interests PK and GA work for Novartis, the sponsor of this trial.
Ethics approval This study was approved by the ethics committees or institutional review boards at each centre and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice according to the International Conference on Harmonisation guidelines. Each patient and/or their parent or legal guardian gave written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
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