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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00333385 |
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Date of registration:
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02/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
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Scientific title:
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Date of first enrolment:
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October 2001 |
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Target sample size:
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120 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00333385 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Dominique Hubert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AP-HP |
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Key inclusion & exclusion criteria
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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
Age minimum:
8 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Pseudomonas Aeruginosa
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Pulmonary Exacerbation
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Intervention(s)
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Drug: ceftazidime
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course
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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
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quality of life scores
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sputum collected at the beginning and the end of each antibiotic course
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the interval between 2 successive IV antibiotic courses
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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