Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333385
Status:
TERMINATED
Last Update Posted:
2006-06-05
First Post:
2006-06-02
Brief Title:
Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
Sponsor:
Association Nationale pour les Traitements A Domicile les Innovations et la Recherche
Organization:
Association Nationale pour les Traitements A Domicile les Innovations et la Recherche
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2001-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 09 sodium chloride and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 09 sodium chloride over 23 hours The daily dose of ceftazidime was 200 mgkg with a maximum dose of 12 g For ceftazidime continuous infusion a loading dose of 60 mgkg maximum 2 g was used All patients also received tobramycin 10 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None