Monitoring of efficacy of preventive antibiotic administration in thoracic surgery

Monitoring of efficacy of antibiotic prophylaxis in thoracic surgery - MONATPRO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000109-22-CZ

Enrollment

Registered

2018-05-02

Start date

2018-05-31

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

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

Interventions

Trade Name: Vulmizolin Product Name: Vulmizolin Pharmaceutical Form: Powder for solution for injection/infusion Trade Name: Azepo Produ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female = 18 years old 2. Selective thoracic surgery with expected lenght more than 1 hour 3. Ability to understand and sign informed consent 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Allergy to cefazolin 2. Ongoing infection treated with systemic antibiotics 3. Renal failure with creatinine clearance lower that 35 ml/min/1,73 m2 based on preoperative laboratory results. 4. Pregnant and breastfeeding woman cannot be enrolled to this study. For women of childbearing potential, the pregnancy will be excluded by pregnancy test prior surgery. 5. Patients with contraindications listed in the currently valid SmPC of the investigational products.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of the trial is to verify whether the antibiotic administration algorithm for prophylactic use in thoracic surgery currently used at the Cardiac surgery department of the University Hospital in Hradec Králové is effective. Furthermore, the aim of this study is to find out whether systemic antibiotic administration reaches sufficient blood levels at the beggining of surgery and corresponds to therapeutic levels that always exceed the minimum inhibitory concentration (MIC). ;Secondary Objective: Secondary objective of this study is to find out whether repeated administration of antibiotics in the current regimen is abundant.; Primary end point(s): Parameters of cephalosporin efficacy are evaluated by monitoring the MIC break point (4 mg /l for MSSA). Efficacy parameters are defined by 20 times the level above the MIC of 4 mg/l. Blood levels of cephalosporins will be monitored and the level is expected higher than 350 mg/l after intravenous administrated dose 2 grams. ;Timepoint(s) of evaluation of this end point: After all blood samples collection	—

Measure

Time frame

Main Objective: Main objective of the trial is to verify whether the antibiotic administration algorithm for prophylactic use in thoracic surgery currently used at the Cardiac surgery department of the University Hospital in Hradec Králové is effective. Furthermore, the aim of this study is to find out whether systemic antibiotic administration reaches sufficient blood levels at the beggining of surgery and corresponds to therapeutic levels that always exceed the minimum inhibitory concentration (MIC). ;Secondary Objective: Secondary objective of this study is to find out whether repeated administration of antibiotics in the current regimen is abundant.; Primary end point(s): Parameters of cephalosporin efficacy are evaluated by monitoring the MIC break point (4 mg /l for MSSA). Efficacy parameters are defined by 20 times the level above the MIC of 4 mg/l. Blood levels of cephalosporins will be monitored and the level is expected higher than 350 mg/l after intravenous administrated dose 2 grams. ;Timepoint(s) of evaluation of this end point: After all blood samples collection

—

Secondary

Measure	Time frame
Secondary end point(s): No secondary end points;Timepoint(s) of evaluation of this end point: No secondary end points	—

Countries

Czech Republic

Contacts

Public ContactReferát klinických hodnocení

Fakultní nemocnice Hradec Králové

helena.linhartova@fnhk.cz420495834250

Outcome results

None listed

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