Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

Medical University of Vienna

Status and phase: Unknown; Phase 4

Conditions: Infection During Renal Replacement Therapy

Treatments: Other: Ceftaroline in CRRT; Other: Ceftaroline in IRRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02007122

CEFTAROLINE_RRT

Details and patient eligibility

About

The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years, able to give written informed consent
• Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
• Renal replacement therapy (continuous or intermittent)

Exclusion criteria

• Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
• An expected survival of less than two days.
• Known pregnancy
• Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
• Ceftaroline as monotherapy for resistent species or fungal infections.
• Other reasons oposing the study participation on the discretion of the investigators

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

IRRT

Experimental group

Description:

Ceftaroline levels are measured in patients receiving intermittent renal replacement therapy

Treatment:

Other: Ceftaroline in IRRT

CRRT

Experimental group

Description:

Ceftaroline levels are measured in patients receiving continuous renal replacement therapy

Treatment:

Other: Ceftaroline in CRRT