Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
- 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
| 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:
- 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
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 | |
| Assistance Publique des Hopitaux de Paris, Hopital Cochin | |
| Paris, France, 75014 | |
| 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 | |
| Hopital de Brabois | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Principal Investigator: | Dominique Hubert, MD | AP-HP |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00333385 History of Changes |
| Other Study ID Numbers: | 01648 |
| Study First Received: | June 2, 2006 |
| Last Updated: | June 2, 2006 |
| Health Authority: | France: Institutional Ethical Committee |
Keywords provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:
|
Ceftazidime Continuous infusion Antibiotic course |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pseudomonas Infections Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections Ceftazidime Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013