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| Sponsor: | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire |
|---|---|
| Collaborators: |
Vaincre la Mucoviscidose GlaxoSmithKline Baxter Healthcare Corporation Roche Pharma AG |
| Information provided by: | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire |
| ClinicalTrials.gov Identifier: | NCT00333385 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis Pseudomonas Aeruginosa Pulmonary Exacerbation |
Drug: ceftazidime |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2001 |
| Estimated Study Completion Date: | April 2004 |
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.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| CHU Grenoble | |
| Grenoble, France, 38043 | |
| Centre hospitalier Dr Schaffner | |
| Lens, France, 62307 | |
| Hopital Jeanne de Flandre | |
| Lille, France, 59000 | |
| Hopital Albert Calmette | |
| Lille, France, 59000 | |
| Hopital Sainte Marguerite | |
| Marseille, France, 13000 | |
| Assistance Publique des Hopitaux de Paris, Hopital Robert Debré | |
| Paris, France, 75019 | |
| Assistance Publique des hopitaux de paris, Hopital Trousseau | |
| Paris, France, 75012 | |
| Hopital de Brabois | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Assistance Publique des Hopitaux de Paris, Hopital Necker | |
| Paris, France, 75015 | |
| Hopital Sud | |
| Rennes, France, 35056 | |
| Centre Héliomarin | |
| Roscoff, France, 29684 | |
| Hopital Hautepierre | |
| Strasbourg, France, 67000 | |
| Hopital Foch | |
| Suresnes, France, 92150 | |
| Hopital Larrey | |
| Toulouse, France, 31000 | |
| Assistance Publique des Hopitaux de Paris, Hopital Cochin | |
| Paris, France, 75014 | |
| Principal Investigator: | Dominique Hubert, MD | AP-HP |
More Information
| Study ID Numbers: | 01648 |
| Study First Received: | June 2, 2006 |
| Last Updated: | June 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00333385 History of Changes |
| Health Authority: | France: Institutional Ethical Committee |
|
Ceftazidime Continuous infusion Antibiotic course |
|
Anti-Infective Agents Fibrosis Pharmacologic Actions Ceftazidime Anti-Bacterial Agents Digestive System Diseases Pathologic Processes |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Therapeutic Uses Pancreatic Diseases Infant, Newborn, Diseases |