Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

Phase 4

Terminated

• Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa; Pulmonary Exacerbation

• Registration Number: NCT00333385
• Lead Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2001-03
• Study Start: 2001-10
• Study Completion: 2004-04
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Last Update Submitted: 2006-06-02
• Study First Posted: 2006-06-05
• Last Update Posted: 2006-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Hopital Albert Calmette; 🇫🇷 Lille, France

Hopital Sainte Marguerite; 🇫🇷 Marseille, France

Hopital Sud; 🇫🇷 Rennes, France

Hopital Hautepierre; 🇫🇷 Strasbourg, France

Assistance Publique des hopitaux de paris, Hopital Trousseau; 🇫🇷 Paris, France

Assistance Publique des Hopitaux de Paris, Hopital Cochin; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France

Assistance Publique des Hopitaux de Paris, Hopital Necker; 🇫🇷 Paris, France

CHU Grenoble; 🇫🇷 Grenoble, France

Hopital Jeanne de Flandre; 🇫🇷 Lille, France

Centre hospitalier Dr Schaffner; 🇫🇷 Lens, France

Hopital de Brabois; 🇫🇷 Vandoeuvre-les-Nancy, France

Centre Héliomarin; 🇫🇷 Roscoff, France

Hopital Larrey; 🇫🇷 Toulouse, France

Assistance Publique des Hopitaux de Paris, Hopital Robert Debré; 🇫🇷 Paris, France