Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy
1 other identifier
interventional
4
1 country
1
Brief Summary
Dosing of ceftaroline in patients with chronic kidney disease is defined, but there is no data on pharmacokinetics and pharmacodynamics of the drug in patients receiving continuous renal replacement therapy (CRRT). The purpose of this study is to determine pharmacokinetics and pharmacodynamics of ceftaroline in a critically ill patient population receiving CRRT, in order to define a dosing recommendation in this population.
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 Mar 2018
Typical duration 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
Study Start
First participant enrolled
March 9, 2018
CompletedFirst Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 18, 2021
March 1, 2021
2.5 years
October 30, 2019
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Half-life
Ceftaroline elimination half-life
1 year
Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Clearance
Ceftaroline clearance
1 year
Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Volume of distribution
Ceftaroline volume of distribution
1 year
Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Sieving coefficient
Continuous renal replacement therapy modality sieving coefficient for ceftaroline
1 year
Secondary Outcomes (1)
Ceftaroline pharmacodynamics in patients receiving continuous renal replacement therapy
1 year
Study Arms (1)
Ceftaroline in CRRT
OTHERCeftaroline levels measured in patients receiving continuous renal replacement therapy
Interventions
Levels of ceftaroline measured in patients receiving CRRT
Eligibility Criteria
You may qualify if:
- Admitted to an intensive care unit
- Receiving CRRT (CVVH, CVVHDF, CVVHD)
- Receiving ceftaroline
You may not qualify if:
- Pregnant patients
- Burn patients
- Patients with toxic epidermal necrolysis or Stevens-Johnson syndrome
- Patients prescribed extended infusion ceftaroline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mojdeh Heavner
University of Maryland, Baltimore
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 5, 2019
Study Start
March 9, 2018
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
March 18, 2021
Record last verified: 2021-03