Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-10-31

Brief Summary

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

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Detailed Description

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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

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IV Ceftazidime/Avibactam

Ceftazidime/avibactam 2.5gm IV q8h for 3 doses

Group Type EXPERIMENTAL

Ceftazidime/avibactam

Intervention Type DRUG

Ceftazidime/avibactam 2.5gm iv q8h for 3 doses

Interventions

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Ceftazidime/avibactam

Ceftazidime/avibactam 2.5gm iv q8h for 3 doses

Intervention Type DRUG

Other Intervention Names

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Avycaz

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No