Safety of inhaled (Tobi (R)) and intravenous tobramycin in young children with cystic fibrosis
Stefanie Hennig, Karen McKay, Suzanna Vidmar, Katie O'Brien, Sonya Stacey, Joyce Cheney, Claire E Wainwright
JOURNAL OF CYSTIC FIBROSIS | ELSEVIER SCIENCE BV | Published : 2014
BACKGROUND: Use of inhaled tobramycin therapy for treatment of Pseudomonas aeruginosa infections in young children with cystic fibrosis (CF) is increasing. Safety data for pre-school children are sparse. METHODS: The aim of this study was to assess the safety of tobramycin solution for inhalation (TOBI®-TSI) administered twice daily for 2 months/course concurrently to intravenous (IV) tobramycin during P. aeruginosa eradication therapy in children (0-5 years). Audiological assessment and estimation of glomerular filtration rate (GFR) was measured prior to any exposure and end of the study. RESULTS: Data were available from 142 patients who were either never exposed to aminoglycosides (n=39),..View full abstract
Awarded by National Health and Medical Research Council
Supported by The National Health and Medical Research Council (ID no. 9937868 and 351541) and the Royal Children's Hospital Foundation, Brisbane, Australia. TOBI (R) was donated by the manufacturer (Pathogenesis, then Chiron, then Novartis) along with the Pari LC plus delivery system. They played no role in the original concept or design of the study; neither did they participate in data analysis nor interpretation and writing of the paper.