Critically Ill, Infection During Renal Replacement Therapy
Conditions
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).
Interventions
OTHERCeftaroline levels in CRRT
Levels of ceftaroline measured in patients receiving CRRT
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Half-life | 1 year | Ceftaroline elimination half-life |
| Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Clearance | 1 year | Ceftaroline clearance |
| Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Volume of distribution | 1 year | Ceftaroline volume of distribution |
| Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Sieving coefficient | 1 year | Continuous renal replacement therapy modality sieving coefficient for ceftaroline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ceftaroline pharmacodynamics in patients receiving continuous renal replacement therapy | 1 year | Percentage of time ceftaroline levels are above the minimum inhibitory concentration for the most likely pathogen(s) |
Countries
United States
Outcome results
None listed