Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy
1 other identifier
interventional
25
1 country
1
Brief Summary
The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.
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 Dec 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 14, 2022
April 1, 2022
8.9 years
December 5, 2013
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
day 15
Study Arms (2)
IRRT
EXPERIMENTALCeftaroline levels are measured in patients receiving intermittent renal replacement therapy
CRRT
EXPERIMENTALCeftaroline levels are measured in patients receiving continuous renal replacement therapy
Interventions
Plasma levels of ceftaroline will be measured in patients receiving CRRT
Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy
Eligibility Criteria
You may qualify if:
- Age \>18 years, able to give written informed consent
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Renal replacement therapy (continuous or intermittent)
You may not qualify if:
- Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- Ceftaroline as monotherapy for resistent species or fungal infections.
- Other reasons oposing the study participation on the discretion of the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1190, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr.
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
December 1, 2013
Primary Completion
November 1, 2022
Study Completion
March 1, 2023
Last Updated
April 14, 2022
Record last verified: 2022-04