Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy
- Conditions
- Infection During Renal Replacement TherapyCritically Ill
- Interventions
- Other: Ceftaroline levels in CRRT
- Registration Number
- NCT04152694
- Lead Sponsor
- University of Maryland, Baltimore
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- Admitted to an intensive care unit
- Receiving CRRT (CVVH, CVVHDF, CVVHD)
- Receiving ceftaroline
- Pregnant patients
- Burn patients
- Patients with toxic epidermal necrolysis or Stevens-Johnson syndrome
- Patients prescribed extended infusion ceftaroline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ceftaroline in CRRT Ceftaroline levels in CRRT Ceftaroline levels measured in patients receiving continuous renal replacement therapy
- Primary Outcome Measures
Name Time Method 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 - 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
Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Clearance 1 year Ceftaroline clearance
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States