A Phase 4 interventional study of ceftazidime in Cystic Fibrosis, Pseudomonas Aeruginosa and Pulmonary Exacerbation, sponsored by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche. Terminated at 15 sites in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2006-06-05.
Sponsored by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche · Phase 4, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 120 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
This study is terminated, as verified in Mar 2001. You cannot join it, but the record below documents what was studied.
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Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche