Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2004-04-30

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Pseudomonas Aeruginosa Pulmonary Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ceftazidime

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Dominique Hubert, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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01648

Identifier Type: -

Identifier Source: org_study_id

Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

ceftazidime

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Vaincre la Mucoviscidose

GlaxoSmithKline

Baxter Healthcare Corporation

Roche Pharma AG

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Principal Investigators

Dominique Hubert, MD

Locations

CHU Grenoble

Centre hospitalier Dr Schaffner

Hopital Albert Calmette

Hopital Jeanne de Flandre

Hopital Sainte Marguerite

Assistance Publique des hopitaux de paris, Hopital Trousseau

Assistance Publique des Hopitaux de Paris, Hopital Cochin

Assistance Publique des Hopitaux de Paris, Hopital Necker

Assistance Publique des Hopitaux de Paris, Hopital Robert Debré

Hopital Sud

Centre Héliomarin

Hopital Hautepierre

Hopital Foch

Hopital Larrey

Hopital de Brabois

Countries

Other Identifiers

01648