Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

June 2, 2006 updated by: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble
      • Lens, France, 62307
        • Centre Hospitalier Dr Schaffner
      • Lille, France, 59000
        • Hôpital Jeanne de Flandre
      • Lille, France, 59000
        • Hôpital Albert Calmette
      • Marseille, France, 13000
        • Hôpital Sainte Marguerite
      • Paris, France, 75012
        • Assistance Publique des hopitaux de paris, Hopital Trousseau
      • Paris, France, 75014
        • Assistance Publique des Hopitaux de Paris, Hopital Cochin
      • Paris, France, 75015
        • Assistance Publique des Hopitaux de Paris, Hopital Necker
      • Paris, France, 75019
        • Assistance Publique des Hopitaux de Paris, Hopital Robert Debré
      • Rennes, France, 35056
        • Hopital Sud
      • Roscoff, France, 29684
        • Centre Héliomarin
      • Strasbourg, France, 67000
        • Hôpital Hautepierre
      • Suresnes, France, 92150
        • Hopital Foch
      • Toulouse, France, 31000
        • Hôpital Larrey
      • Vandoeuvre-les-Nancy, France, 54511
        • Hôpital de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

GlaxoSmithKline
Roche Pharma AG
Baxter Healthcare Corporation
Vaincre la Mucoviscidose

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (ESTIMATE)

June 5, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2006

Last Update Submitted That Met QC Criteria

June 2, 2006

Last Verified

March 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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