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Completed

NCT Number: NCT02504827

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

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

Completed

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern California

Los Angeles, California, 90089, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftazidime/avibactam

Drug

Ceftazidime/avibactam 2.5gm iv q8h for 3 doses

Other names: Avycaz

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 8 hours

  2. Peak Sputum Concentration

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2015
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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