title: Tobramycin once- vs thrice-daily for elective intravenous antipseudomonal therapy in pediatric cystic fibrosis patients.
abstract: OBJECTIVE
  We hypothesized that a single intravenous (iv) tobramycine infusion (treatment B) would have equivalent anti-infectious efficacy in chronic Pseudomonas aeruginosa (PA) infection in cystic fibrosis (CF) as the commonly performed treatment of three doses (treatment A) . Toxicity and practicability may even be improved in the single-dose regimen.
  
  
  METHODS
  This was a randomized crossover study comparing outcome after 14 and 35 days. The primary end-point was a decrease in the leukocyte count, and the secondary end-points were clinical and lung function parameters, Pseudomonas quantification in sputum, and inflammation markers (immunoglobulin G, C-reactive protein) in serum. 30 patients (20 female, mean age 11.2 years, mean age range 1.7-18.1 years) received elective 14-day courses of treatments A or B, followed by the alternative treatment after a mean interval of 37 (+/- 21) weeks.
  
  
  RESULTS
  With the exception of PA density, there were no significant differences between both treatment strategies after 14 days of treatment. After 35 days of treatment, there were no significant changes in the leukocyte count and inflammation markers. Both treatment strategies reduced the bacterial load in the airways, as reflected by a decreased PA density in sputum. Nephrotoxicity was equal in both groups, with a transient slight elevation of urinary N-acetyl-beta-glucosaminidase concentrations. Standard audiometry tests revealed no evidence of a hearing impairment in any patient following therapy. Mean body weight increased during the study period by 0.5 kg. Forced expiratory volume increased by approximately 5% of the predicted volume, forced vital capacity increased by 2% of predicted capacity, and forced mid expiratory flow rate increased by 7% (A) or 4% (B) of the predicted normal value, although these changes were not statistically significant.
  
  
  CONCLUSIONS
  We conclude that tobramycin given in a daily single dose (with the advantage of being more practical in a home environment) has an efficacy equal to that of three daily doses in terms of elective antipseudomonal therapy in clinically stable patients with CF.
authors.affiliation: University Children's Hospital, 72076, Tübingen, Germany. joachim.riethmueller@med.uni-tuebingen.de
authors.forename: J
authors.initials: J
authors.lastname: Riethmueller
authors.forename: M
authors.initials: M
authors.lastname: Ballmann
authors.forename: T W
authors.initials: TW
authors.lastname: Schroeter
authors.forename: P
authors.initials: P
authors.lastname: Franke
authors.forename: R
authors.initials: R
authors.lastname: von Butler
authors.forename: A
authors.initials: A
authors.lastname: Claass
authors.forename: S
authors.initials: S
authors.lastname: Junge
authors.forename: G
authors.initials: G
authors.lastname: Doering
authors.forename: M
authors.initials: M
authors.lastname: Stern
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000150:complications*; D005260:Female; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000473:pathology; D011552:Pseudomonas Infections / Q000188:drug therapy* / Q000473:pathology; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin