Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study

Abstract

Objective: Antibiotic eradication treatment is the standard-of-care for cystic fibrosis (CF) patients with early Pseudomonas aeruginosa (Pa)-infection; however, evidence from placebo-controlled trials is limited.

Methods: This double-blind, placebo-controlled trial randomised CF patients <7 years (N = 51) with early Pa-infection to tobramycin inhalation solution (TOBI 300 mg) or placebo (twice daily) for 28 days with an optional cross-over on Day 35. Primary endpoint was proportion of patients having throat swabs/sputum free of Pa on Day 29.

Results: On Day 29, 84.6% patients in the TOBI versus 24.0% in the placebo group were Pa-free (p < 0.001). At the end of the cross-over period, 76.0% patients receiving TOBI in the initial 28 days were Pa-free compared to 47.8% receiving placebo initially. Adverse events were consistent with the TOBI safety profile with no differences between TOBI and placebo.

Conclusion: TOBI was effective in eradicating early Pa-infection with a favourable safety profile in young CF patients.

Trial registration number: NCT01082367.

Keywords: Early eradication; Paediatric patient; Placebo-controlled; Recurrence; Tobramycin inhalation solution.