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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00333385
Other study ID # 01648
Secondary ID
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
Est. primary completion date
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


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
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