NCT02504827

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Ceftazidime/avibactam	Ceftazidime/avibactam 2.5gm iv q8h for 3 doses

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-07-22
• Last updated: 2018-11-27
• Results posted: 2018-11-27

Locations

1 site across 1 country: United States