Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00333385
• Other study ID #: 01648
• Status: Terminated
• Phase: Phase 4
• First received: June 2, 2006
• Last updated: June 2, 2006
• Start date: October 2001
• Est. completion date: April 2004

Study information

• Verified date: March 2001
• Source: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: April 2004
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pulmonary Exacerbation

Intervention

Drug:
• ceftazidime

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

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