NCT00333385

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2001

Typical duration for phase_4

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
Last Updated

June 5, 2006

Status Verified

March 1, 2001

First QC Date

June 2, 2006

Last Update Submit

June 2, 2006

Conditions

Cystic FibrosisPseudomonas AeruginosaPulmonary Exacerbation

Keywords

CeftazidimeContinuous infusionAntibiotic course

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Interventions

ceftazidimeDRUG

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • allergy to ceftazidime or tobramycin
  • bronchial colonization with Burkholderia cepacia
  • renal impairment
  • history of lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU Grenoble

Grenoble, 38043, France

Location

Centre hospitalier Dr Schaffner

Lens, 62307, France

Location

Hopital Albert Calmette

Lille, 59000, France

Location

Hopital Jeanne de Flandre

Lille, 59000, France

Location

Hopital Sainte Marguerite

Marseille, 13000, France

Location

Assistance Publique des hopitaux de paris, Hopital Trousseau

Paris, 75012, France

Location

Assistance Publique des Hopitaux de Paris, Hopital Cochin

Paris, 75014, France

Location

Assistance Publique des Hopitaux de Paris, Hopital Necker

Paris, 75015, France

Location

Assistance Publique des Hopitaux de Paris, Hopital Robert Debré

Paris, 75019, France

Location

Hopital Sud

Rennes, 35056, France

Location

Centre Héliomarin

Roscoff, 29684, France

Location

Hopital Hautepierre

Strasbourg, 67000, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Hopital Larrey

Toulouse, 31000, France

Location

Hopital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Cystic FibrosisPseudomonas Infections

Interventions

Ceftazidime

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CephaloridineCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dominique Hubert, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 5, 2006

Study Start

October 1, 2001

Study Completion

April 1, 2004

Last Updated

June 5, 2006

Record last verified: 2001-03

Locations

FR(15)