The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
Each patient received two successive IV antibiotic courses during a period of pulmonary exacerbation. One of these courses was delivered as thrice daily 30-minute infusions of ceftazidime in 100 ml of 0.9% sodium chloride, and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 0.9% sodium chloride, over 23 hours. The daily dose of ceftazidime was 200 mg/kg, with a maximum dose of 12 g. For ceftazidime continuous infusion, a loading dose of 60 mg/kg (maximum 2 g) was used. All patients also received tobramycin (10 mg/kg), in the form of one 30-minute infusion per day. Portable devices were used: Intermate® SV 200 (Baxter) for the 30-minute short infusions of ceftazidime and tobramycin, Infusor® LV10 (Baxter) for continuous infusion of ceftazidime.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
CHU Grenoble
Grenoble, France
Centre hospitalier Dr Schaffner
Lens, France
Hopital Albert Calmette
Lille, France
Hopital Jeanne de Flandre
Lille, France
Hopital Sainte Marguerite
Marseille, France
Assistance Publique des hopitaux de paris, Hopital Trousseau
Paris, France
Assistance Publique des Hopitaux de Paris, Hopital Cochin
Paris, France
Assistance Publique des Hopitaux de Paris, Hopital Necker
Paris, France
Assistance Publique des Hopitaux de Paris, Hopital Robert Debré
Paris, France
Hopital Sud
Rennes, France
...and 5 more locations
Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value
the interval between 2 successive IV antibiotic courses
quality of life scores
sputum collected at the beginning and the end of each antibiotic course
plasma ceftazidime concentration at steady state (Css) for ceftazidime continuous infusion, and before (C trough), 30 minutes (Cmax) and 4 hours after (C4) the beginning of ceftazidime short infusion
C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course
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