Premium
Placebo‐controlled, double‐blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis
Author(s) -
Wiesemann Heinz Georg,
Steinkamp Gratiana,
Ratjen Felix,
Bauernfeind Adolf,
Przyklenk Barbara,
Döring Gerd,
von der Hardt Horst
Publication year - 1998
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/(sici)1099-0496(199802)25:2<88::aid-ppul3>3.0.co;2-j
Subject(s) - tobramycin , cystic fibrosis , medicine , pseudomonas aeruginosa , placebo , sputum , antibiotics , inhalation , respiratory disease , placebo controlled study , gastroenterology , lung , anesthesia , double blind , microbiology and biotechnology , pathology , bacteria , biology , tuberculosis , genetics , alternative medicine
In chronic Pseudomonas aeruginosa pulmonary infection of patients with cystic fibrosis (CF), antibiotic therapy generally fails to eradicate the bacterial pathogen. The mucoid bacterial phenotype, high sputum production by the host, and low airway levels of antibiotics seem to be responsible for the observed decrease in antibiotic efficacy. We hypothesized that early antibiotic treatment by inhalation in CF patients may be able to prevent or at least delay airway infection. In a prospective placebo‐controlled, double‐blind, randomized multicenter study, 22 CF patients received either 80 mg b.i.d. of aerosolized tobramycin or placebo for a period of 12 months shortly after the onset of P. aeruginosa pulmonary colonization. Two patients in the tobramycin and six patients in the placebo group stopped inhalation before the 12 month treatment period. Using life table analysis, the time to conversion from a P. aeruginosa ‐positive to a P. aeruginosa ‐negative respiratory culture was significantly shorter in the tobramycin‐treated group than in the placebo group ( P < 0.05, log rank test). Lung function parameters and markers of inflammation did not change in either group during treatment. The results of this study suggest that early tobramycin inhalation may prevent and/or delay P. aeruginosa pulmonary infection in CF patients. Pediatr. Pulmonol. 1998; 25:88–92. © 1998 Wiley‐Liss, Inc.