Clinical trial NCT04152694: Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy
Official title: Ceftaroline Pharmacokinetics in Critically Ill Patients Receiving Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection During Renal Replacement Therapy
Critically Ill
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Half-life
timeFrame: 1 year
measure: Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Clearance
timeFrame: 1 year
measure: Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Volume of distribution
timeFrame: 1 year
measure: Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Sieving coefficient
timeFrame: 1 year
Secondary outcomes:
measure: Ceftaroline pharmacodynamics in patients receiving continuous renal replacement therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Mojdeh Heavner
role: PRINCIPAL_INVESTIGATOR
References: