Ceftaroline (Zinforo®) as antibiotic prophylaxis for coronary bypass surgery: An In-vivo microdialysis study

Ceftaroline (Zinforo®) as antibiotic prophylaxis for CABG-surgery: An In-vivo microdialysis study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002508-29-AT

Enrollment

Registered

2017-12-04

Start date

2018-02-09

Completion date

Unknown

Last updated

2026-05-18

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

Conditions

Antibiotic prophylaxis for CABG surgery MedDRA version: 20.0 Level: LLT Classification code 10036894 Term: Prophylactic antibiotic therapy System Organ Class: 100000004865

Interventions

Trade Name: Zinforo Pharmaceutical Form: Powder for concentrate for solution for injection/infusion INN or Proposed INN: ceftaroline CAS Number: 229016-73-3 Current Sponsor code: CEFTAROPROPH Other de

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Written informed consent -Planned coronary artery bypass grafting with left internal mammary artery bypass -Planned use of cardiopulmonary bypass -Age: > 18 and 40% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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

Exclusion criteria

Exclusion criteria: -Inability to give informed consent -Know allergy to cephalosporins or penicillin or ceftaroline -Preoperative antibiotic therapy -Signs of infection preoperatively -Re-operation or emergency procedure -Planned use of bilateral internal mammary artery bypass -Preoperative renal failure -Chronic severe renal insufficiency including hemodialysis -Chronic severe liver disease -BMI > 35 -Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus -Pregnant women

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure free, microbiologically active concentrations of ceftaroline in plasma, subcutaneous tissue and lung parenchyma in order to evaluate whether adequate concentrations of ceftaroline are achieved in this special cohort of patients for antibiotic prophylaxis and treatment of complicated skin and soft-tissue infections and community acquired pneumonia.;Secondary Objective: - To compare free concentrations of ceftaroline in subcutaneous tissue with a presumed perfusion deficit (on the left side of sternotomy incision due to LIMA preparation) and subcutaneus tissue with normal perfusion (on the right side of the sternotomy incision) - To compare bolus- and continuous administration of ceftaroline using identical doses;Primary end point(s): - Perioperative pharmacokinetic profiles of ceftaroline in plasma, subcutaneous tissue and lung parenchyma ;Timepoint(s) of evaluation of this end point: In the bolus-group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals during administration of each bolus and every 2h after completion of the bolus until the next bolus. The last sample will be drawn 1440mins after the first administration. In the continuous group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals for the first 10h of continuous adminstration and every 2h thereafter until 1440mins after the first administration.	—

Measure

Time frame

Main Objective: To measure free, microbiologically active concentrations of ceftaroline in plasma, subcutaneous tissue and lung parenchyma in order to evaluate whether adequate concentrations of ceftaroline are achieved in this special cohort of patients for antibiotic prophylaxis and treatment of complicated skin and soft-tissue infections and community acquired pneumonia.;Secondary Objective: - To compare free concentrations of ceftaroline in subcutaneous tissue with a presumed perfusion deficit (on the left side of sternotomy incision due to LIMA preparation) and subcutaneus tissue with normal perfusion (on the right side of the sternotomy incision) - To compare bolus- and continuous administration of ceftaroline using identical doses;Primary end point(s): - Perioperative pharmacokinetic profiles of ceftaroline in plasma, subcutaneous tissue and lung parenchyma ;Timepoint(s) of evaluation of this end point: In the bolus-group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals during administration of each bolus and every 2h after completion of the bolus until the next bolus. The last sample will be drawn 1440mins after the first administration. In the continuous group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals for the first 10h of continuous adminstration and every 2h thereafter until 1440mins after the first administration.

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Secondary

Measure	Time frame
Secondary end point(s): - Difference of pharmacokinetics of ceftaroline between plasma, subcutaneous tissue and lung parenchyma - Difference of pharmacokinetic profiles between intermittent bolus administration and continuous administration of ceftaroline;Timepoint(s) of evaluation of this end point: In the bolus-group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals during administration of each bolus and every 2h after completion of the bolus until the next bolus. The last sample will be drawn 1440mins after the first administration. In the continuous group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals for the first 10h of continuous adminstration and every 2h thereafter until 1440mins after the first administration.	—

Measure

Time frame

Secondary end point(s): - Difference of pharmacokinetics of ceftaroline between plasma, subcutaneous tissue and lung parenchyma - Difference of pharmacokinetic profiles between intermittent bolus administration and continuous administration of ceftaroline;Timepoint(s) of evaluation of this end point: In the bolus-group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals during administration of each bolus and every 2h after completion of the bolus until the next bolus. The last sample will be drawn 1440mins after the first administration. In the continuous group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals for the first 10h of continuous adminstration and every 2h thereafter until 1440mins after the first administration.

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Countries

Austria

Contacts

Public ContactDepartment of Cardiac Anaesthesia

Medical University Vienna

maximilian.edlinger-stanger@meduniwien.ac.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026