Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

This study has been terminated.
Sponsor:
Collaborators:
Vaincre la Mucoviscidose
GlaxoSmithKline
Baxter Healthcare Corporation
Roche Pharma AG
Information provided by:
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT00333385
First received: June 2, 2006
Last updated: NA
Last verified: March 2001
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • 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:
  • 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
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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333385

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
Sponsors and Collaborators
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Vaincre la Mucoviscidose
GlaxoSmithKline
Baxter Healthcare Corporation
Roche Pharma AG
Investigators
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:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014