Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 4

Conditions: Critically Ill; Infection During Renal Replacement Therapy

Treatments: Other: Ceftaroline levels in CRRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04152694

HP-00077498

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Ceftaroline in CRRT

Other group

Description:

Ceftaroline levels measured in patients receiving continuous renal replacement therapy

Treatment:

Other: Ceftaroline levels in CRRT