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Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis, Pseudomonas Aeruginosa, Pulmonary Exacerbation

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

ceftazidime

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Ceftazidime, Continuous infusion, Antibiotic course

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / 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

Outcomes

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

Full Information

NCT ID

NCT00333385

First Posted

June 2, 2006

Last Updated

June 2, 2006

Sponsor

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

Collaborators

Vaincre la Mucoviscidose, GlaxoSmithKline, Baxter Healthcare Corporation, Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT00333385

Brief Title

Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2001

Overall Recruitment Status

Terminated

Study Start Date

October 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

Vaincre la Mucoviscidose, GlaxoSmithKline, Baxter Healthcare Corporation, Roche Pharma AG

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Pseudomonas Aeruginosa, Pulmonary Exacerbation

Keywords

Ceftazidime, Continuous infusion, Antibiotic course

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ceftazidime

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

the interval between 2 successive IV antibiotic courses

Title

quality of life scores

Title

sputum collected at the beginning and the end of each antibiotic course

Title

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

Title

C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique Hubert, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Grenoble

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Centre hospitalier Dr Schaffner

City

Lens

ZIP/Postal Code

62307

Country

France

Facility Name

Hopital Albert Calmette

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Hopital Jeanne de Flandre

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Hopital Sainte Marguerite

City

Marseille

ZIP/Postal Code

13000

Country

France

Facility Name

Assistance Publique des hopitaux de paris, Hopital Trousseau

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Assistance Publique des Hopitaux de Paris, Hopital Cochin

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Assistance Publique des Hopitaux de Paris, Hopital Necker

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Assistance Publique des Hopitaux de Paris, Hopital Robert Debré

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Hopital Sud

City

Rennes

ZIP/Postal Code

35056

Country

France

Facility Name

Centre Héliomarin

City

Roscoff

ZIP/Postal Code

29684

Country

France

Facility Name

Hopital Hautepierre

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Hopital Foch

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

Hopital Larrey

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Hopital de Brabois

City

Vandoeuvre-les-Nancy

ZIP/Postal Code

54511

Country

France

12. IPD Sharing Statement

Learn more about this trial

Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

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