Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04152694
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2019-10-30
Brief Title:
Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Ceftaroline Pharmacokinetics in Critically Ill Patients Receiving Continuous Renal Replacement Therapy
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Ceftaroline fosamil is a time-dependent hydrophilic bactericidal fifth generation cephalosporin that was FDA approved in 2010 for community acquired pneumonia and skin and skin structure infections Ceftaroline is FDA approved for both Gram-positive and Gram-negative organisms Gram-positive organisms covered are Staphylococcus aureus methicillin resistant and methicillin sensitive strains Streptococcus agalactiae Streptococcus pneumonia and Streptococcus pyogenes Gram-negative coverage includes Escherichia coli Haemophilus influenza Klebsiella pneumonia and Klebsiella oxytoca In order for ceftaroline to exhibit effective bacterial killing it requires that a certain percentage of the dosing interval is spent above the MIC
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 CRRT modes that patients may be receiving in this trial include continuous veno-venous hemofiltration CVVH continuous veno-venous hemodialysis CVVHD and continuous veno-venous hemodiafiltration CVVHDF
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 CRRT modes that patients may be receiving in this trial include continuous veno-venous hemofiltration CVVH continuous veno-venous hemodialysis CVVHD and continuous veno-venous hemodiafiltration CVVHDF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None