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
Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study / F. Ratjen, A. Moeller, M.L. Mckinney, I. Asherova, N. Alon, R. Maykut, G. Angyalosi, O. Bede, K. Bolbas, V. Bulatov, E. Chertok, C. Colombo, M. Fayon, F. Gonczi, E. Gouda, J. Hammermann, A. Munck, M. Solomon, J. Tsanakas. - In: JOURNAL OF CYSTIC FIBROSIS. - ISSN 1569-1993. - 18:1(2019 Jan), pp. 78-85.
|Titolo:||Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study|
|Parole Chiave:||Early eradication; Paediatric patient; Placebo-controlled; Recurrence; Tobramycin inhalation solution; Pediatrics, Perinatology and Child Health; Pulmonary and Respiratory Medicine|
|Settore Scientifico Disciplinare:||Settore MED/38 - Pediatria Generale e Specialistica|
|Data di pubblicazione:||gen-2019|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.jcf.2018.04.002|
|Appare nelle tipologie:||01 - Articolo su periodico|