Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
November 27, 2018
CompletedNovember 27, 2018
October 1, 2018
1.1 years
July 20, 2015
September 4, 2018
October 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Peak Plasma Concentration (Cmax)
8 hours
Peak Sputum Concentration
8 hours
Study Arms (1)
IV Ceftazidime/Avibactam
EXPERIMENTALCeftazidime/avibactam 2.5gm IV q8h for 3 doses
Interventions
Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Eligibility Criteria
You may qualify if:
- Diagnosis of CF based on positive sweat chloride or know CF mutation
- Age \> 17 years
- Able to spontaneously expectorate sputum
You may not qualify if:
- Any clinically significant laboratory abnormality
- Presence of an ongoing acute pulmonary exacerbation
- Pregnancy
- Serious past allergy to a beta-lactam antibiotic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90089, United States
Related Publications (1)
Bensman TJ, Wang J, Jayne J, Fukushima L, Rao AP, D'Argenio DZ, Beringer PM. Pharmacokinetic-Pharmacodynamic Target Attainment Analyses To Determine Optimal Dosing of Ceftazidime-Avibactam for the Treatment of Acute Pulmonary Exacerbations in Patients with Cystic Fibrosis. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00988-17. doi: 10.1128/AAC.00988-17. Print 2017 Oct.
PMID: 28784670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Beringer
- Organization
- University of Southern California
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Beringer, PharmD
University of Southern California
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 22, 2015
Study Start
September 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 27, 2018
Results First Posted
November 27, 2018
Record last verified: 2018-10