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

EARLY study group, Felix Ratjen, Alexander Moeller, Martha L. McKinney, Irina Asherova, Nipa Alon, Robert Maykut, Gerhild Angyalosi, Olga Bede, Katalin Bolbas, Vladimir Bulatov, Elena Chertok, Carla Colombo, Michael Fayon, Ferenc Gonczi, Essam Gouda, Jutta Hammermann, Anne Munck, Melinda Solomon, John Tsanakas

Research output: Contribution to journalArticle

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

Original languageEnglish
Pages (from-to)78-85
JournalJournal of Cystic Fibrosis
Volume18
Issue number1
DOIs
Publication statusPublished - 2019

Keywords

  • Early eradication
  • Paediatric patient
  • Placebo-controlled
  • Recurrence
  • Tobramycin inhalation solution

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pulmonary and Respiratory Medicine

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    EARLY study group, Ratjen, F., Moeller, A., McKinney, M. L., Asherova, I., Alon, N., Maykut, R., Angyalosi, G., Bede, O., Bolbas, K., Bulatov, V., Chertok, E., Colombo, C., Fayon, M., Gonczi, F., Gouda, E., Hammermann, J., Munck, A., Solomon, M., & Tsanakas, J. (2019). Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. Journal of Cystic Fibrosis, 18(1), 78-85. https://doi.org/10.1016/j.jcf.2018.04.002