Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504827
• Other study ID #: APP-15-01273
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of CF based on positive sweat chloride or know CF mutation

• Age > 17 years

• Able to spontaneously expectorate sputum

Exclusion Criteria:

• Any clinically significant laboratory abnormality

• Presence of an ongoing acute pulmonary exacerbation

• Pregnancy

• Serious past allergy to a beta-lactam antibiotic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Ceftazidime/avibactam
Ceftazidime/avibactam 2.5gm iv q8h for 3 doses

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)		8 hours
Primary	Peak Sputum Concentration		8 hours