Blood concentration of Ceftaroline during renal replacement therapy

Multiple-dose Pharmacokinetics of Ceftaroline during continuous and intermittent renal replacement therapy in patients requiring renal replacement therapy - CEFTAROLINE_RRT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003914-42-AT

Enrollment

Registered

2013-09-24

Start date

2013-11-06

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial infection in patients recieving renal replacement therapy MedDRA version: 16.0 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Zinforo Product Name: Zinforo Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Ceftaroline fosamil CAS Number: 400827-46-5 Other descriptive name: CEFTAROLINE FOS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Age >18 years b) Suspected or proven bacterial infection requiring parenteral antibiotic therapy. c) Renal replacement therapy (continuous or intermittent) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine the correct dosage for Ceftaroline during renal replacement therapy.;Secondary Objective: Not applicable;Primary end point(s): AUC of Ceftaroline during RRT;Timepoint(s) of evaluation of this end point: In the intermittent RRT arm: at timepoints 0, 0.5, 1, 2, 3.5, 4 hours and after the end of the frirst dialysis session, and pre-dialysis, post-dialysis and post infusion over 15 days. In the continuous arm: at timepoints 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 and 49 hours starting from the first dose of ceftaroline.	—

Measure

Time frame

Main Objective: Determine the correct dosage for Ceftaroline during renal replacement therapy.;Secondary Objective: Not applicable;Primary end point(s): AUC of Ceftaroline during RRT;Timepoint(s) of evaluation of this end point: In the intermittent RRT arm: at timepoints 0, 0.5, 1, 2, 3.5, 4 hours and after the end of the frirst dialysis session, and pre-dialysis, post-dialysis and post infusion over 15 days. In the continuous arm: at timepoints 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 and 49 hours starting from the first dose of ceftaroline.

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Secondary

Measure	Time frame
Secondary end point(s): half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction;Timepoint(s) of evaluation of this end point: In the intermittent RRT arm: at timepoints 0, 0.5, 1, 2, 3.5, 4 hours and after the end of the frirst dialysis session, and pre-dialysis, post-dialysis and post infusion over 14 days. In the continuous arm: at timepoints 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 and 49 starting from the first dose of ceftaroline.	—

Measure

Time frame

Secondary end point(s): half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction;Timepoint(s) of evaluation of this end point: In the intermittent RRT arm: at timepoints 0, 0.5, 1, 2, 3.5, 4 hours and after the end of the frirst dialysis session, and pre-dialysis, post-dialysis and post infusion over 14 days. In the continuous arm: at timepoints 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 and 49 starting from the first dose of ceftaroline.

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Countries

Austria

Contacts

Public ContactFlorian Thalhammer

Medizinische Universität Wien, Univ.-Klinik für Innere Medizin I, Klinische Abteilung für Infetionen und Tropenmedizin

florian.thalhammer@meduniwien.ac.at00431404004440

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026