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Arch Dis Child 1998;78:536-539 ( June )

Efficacy, tolerance, and pharmacokinetics of once daily tobramycin for pseudomonas exacerbations in cystic fibrosis

P Vic,a S Ategbo,a D Turck,a M O Husson,b V Launay,a G A Loeuille,d A Sardet,a A Deschildre,a D Druon,e C Arrouet-Lagandec

a Department of Paediatrics, Lille University Hospital, Lille, France, b Department of Bacteriology, Lille University Hospital, c Department of Otorhinolaryngology, Lille University Hospital, d Department of Paediatrics, City Hospital, Dunkirk, France, e Department of Paediatrics, City Hospital, Camiers, France

Correspondence to: Professor Dominique Turck, Centre de Soins pour la Mucoviscidose, Clinique de Pédiatrie, Hôpital Jeanne de Flandre, 59037 Lille Cédex, France. email: dturck{at}chru-lille.fr


Accepted 16 January 1998

OBJECTIVE---To compare once daily with thrice daily tobramycin for treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis.
DESIGN---22 patients with cystic fibrosis, mean (SD) age 11 (3.4) years (range 5.6-19.3), with pulmonary pseudomonas exacerbations were randomly assigned to receive a 14 day course of tobramycin (15 mg/kg/day) either in three infusions (group A) (n = 10) or a single daily infusion (group B) (n = 12), combined with ceftazidime (200 mg/kg/day as three intravenous injections). Efficacy was assessed by comparison of pulmonary, nutritional, and inflammatory indices on days 1 and 14. Cochlear and renal tolerance were assessed on days 1 and 14. Tobramycin concentration was measured in serum and sputum 1, 2, 3, 4, 8, and 24 hours after the start of the infusion. Analysis was by non-parametric Wilcoxon test.
RESULTS---Variables improving (p < 0.05) in both groups A and B were, respectively: weight/height (+4% and +3.1%), plasma prealbumin (+66 and +63 mg/l), forced vital capacity (FVC) (+14% and +11%), forced expiratory volume in one second (+15% and +14%), and forced expiratory flow between 25% and 75% of FVC (+13% and +21%). Improvement was not significantly different between groups. Renal and cochlear indices remained within the normal range. Serum peak concentration of tobramycin on day 1 was 13.2 (7.1) mg/l in group A and 42.5 (11.2) mg/l in group B (p < 0.001); serum trough was 1.1 (0.8) mg/l in group A and 0.3 (0.2) mg/l in group B (p < 0.01). Tobramycin concentrations in sputum were two to three times higher in group B than group A.
CONCLUSIONS---Once daily tobramycin combined with three injections of ceftazidime is safe and effective for the treatment of pseudomonas exacerbations in cystic fibrosis patients.

Keywords: cystic fibrosis; antibiotics; aminoglycosides; Pseudomonas aeruginosa

© 1998 by Archives of Disease in Childhood


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