Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Ceftazidime/avibactam

• Registration Number: NCT02504827
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Study Start: 2015-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2018-09-04
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Results First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Diagnosis of CF based on positive sweat chloride or know CF mutation
• Age > 17 years
• Able to spontaneously expectorate sputum

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Exclusion Criteria

• Any clinically significant laboratory abnormality
• Presence of an ongoing acute pulmonary exacerbation
• Pregnancy
• Serious past allergy to a beta-lactam antibiotic

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV Ceftazidime/Avibactam	Ceftazidime/avibactam	Ceftazidime/avibactam 2.5gm IV q8h for 3 doses

Primary Outcome Measures

Name	Time	Method
Peak Sputum Concentration	8 hours
Peak Plasma Concentration (Cmax)	8 hours

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States