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

Phase 4

• Conditions: Infection During Renal Replacement Therapy
• Interventions: Other: Ceftaroline in CRRT; Other: Ceftaroline in IRRT

• Registration Number: NCT02007122
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-11
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRRT	Ceftaroline in CRRT	Ceftaroline levels are measured in patients receiving continuous renal replacement therapy
IRRT	Ceftaroline in IRRT	Ceftaroline levels are measured in patients receiving intermittent renal replacement therapy

Primary Outcome Measures

Name	Time	Method
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.	day 15	Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria