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NCT04152694 Clinical Trial

Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy

Critically Ill Clinical Trial

Official title:
Ceftaroline Pharmacokinetics in Critically Ill Patients Receiving Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04152694
Other study ID # HP-00077498
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 9, 2018
Est. completion date September 1, 2020

Study information
Verified date March 2021
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted to an intensive care unit - Receiving CRRT (CVVH, CVVHDF, CVVHD) - Receiving ceftaroline Exclusion Criteria: - Pregnant patients - Burn patients - Patients with toxic epidermal necrolysis or Stevens-Johnson syndrome - Patients prescribed extended infusion ceftaroline

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ceftaroline levels in CRRT
Levels of ceftaroline measured in patients receiving CRRT

Locations
Country Name City State
United States University of Maryland Medical Center Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Half-life Ceftaroline elimination half-life 1 year
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Clearance Ceftaroline clearance 1 year
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Volume of distribution Ceftaroline volume of distribution 1 year
Primary 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 Ceftaroline pharmacodynamics in patients receiving continuous renal replacement therapy Percentage of time ceftaroline levels are above the minimum inhibitory concentration for the most likely pathogen(s) 1 year
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