Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Ceftaroline in CRRT
Ceftaroline levels measured in patients receiving continuous renal replacement therapy
  • Other: Ceftaroline levels in CRRT
    Levels of ceftaroline measured in patients receiving CRRT

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Mojdeh Heavner
mheavner@rx.umaryland.edu

More Details

NCT ID
NCT04152694
Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Mojdeh S Heavner, PharmD
410-706-3498
mheavner@rx.umaryland.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.