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Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
This study has been terminated.
Study NCT00333385   Information provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
First Received: June 2, 2006   No Changes Posted

June 2, 2006
June 2, 2006
October 2001
 
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
Same as current
No Changes Posted
  • 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
Same as current
 
Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
 

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.

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
  • Cystic Fibrosis
  • Pseudomonas Aeruginosa
  • Pulmonary Exacerbation
Drug: ceftazidime
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
120
April 2004
 

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
Both
8 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00333385
 
01648
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
  • Vaincre la Mucoviscidose
  • GlaxoSmithKline
  • Baxter Healthcare Corporation
  • Roche Pharma AG
Principal Investigator: Dominique Hubert, MD AP-HP
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP