Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT02504827
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2015-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF
Status:
COMPLETED
Status Verified Date:
2018-10
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 purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.
Detailed Description:
Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents.
While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.
While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.
Study Oversight
Has Oversight DMC:
False
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?: