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Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504827
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Beringer, 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Ceftazidime/avibactam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF
Study Start Date : September 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: IV Ceftazidime/Avibactam
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Drug: Ceftazidime/avibactam
Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Other Name: Avycaz




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 8 hours ]
  2. Peak Sputum Concentration [ Time Frame: 8 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504827


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Paul Beringer, PharmD University of Southern California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Beringer, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02504827    
Other Study ID Numbers: APP-15-01273
First Posted: July 22, 2015    Key Record Dates
Results First Posted: November 27, 2018
Last Update Posted: November 27, 2018
Last Verified: October 2018
Keywords provided by Paul Beringer, University of Southern California:
pharmacokinetics
ceftazidime/avibactam
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action