Blood concentration of Ceftaroline during renal replacement therapy

Phase 1

Conditions: Bacterial infection in patients recieving renal replacement therapy
MedDRA version: 16.0Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2013-003914-42-AT

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>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.

Secondary Outcome Measures

Name	Time	Method
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. <br><br>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.