Cystic Fibrosis Clinical Trial
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.
Status | Terminated |
Enrollment | 120 |
Est. completion date | April 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years and older |
Eligibility |
Inclusion Criteria: - patients with cystic fibrosis older than 8 years - with chronic Pseudomonas aeruginosa infection of the respiratory tract - with at least 2 courses of IV antibiotic in the year before enrolment - at the time of a pulmonary exacerbation Exclusion Criteria: - allergy to ceftazidime or tobramycin - bronchial colonization with Burkholderia cepacia - renal impairment - history of lung transplantation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | 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 Cochin | Paris | |
France | Assistance Publique des Hopitaux de Paris, Hopital Necker | Paris | |
France | Assistance Publique des Hopitaux de Paris, Hopital Robert Debré | Paris | |
France | Assistance Publique des hopitaux de paris, Hopital Trousseau | Paris | |
France | Hopital Sud | Rennes | |
France | Centre Héliomarin | Roscoff | |
France | Hopital Hautepierre | Strasbourg | |
France | Hopital Foch | Suresnes | |
France | Hopital Larrey | Toulouse | |
France | Hopital de Brabois | Vandoeuvre-les-Nancy |
Lead Sponsor | Collaborator |
---|---|
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche | Baxter Healthcare Corporation, GlaxoSmithKline, Roche Pharma AG, Vaincre la Mucoviscidose |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |||
Secondary | the interval between 2 successive IV antibiotic courses | |||
Secondary | quality of life scores | |||
Secondary | sputum collected at the beginning and the end of each antibiotic course | |||
Secondary | 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 | |||
Secondary | C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course |
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