Monitoring of efficacy of preventive antibiotic administration in thoracic surgery

Phase 1

• Conditions: Antibiotic prophylaxis in thoracic surgery; MedDRA version: 20.0 Level: LLT Classification code 10036894 Term: Prophylactic antibiotic therapy System Organ Class: 100000004865; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2018-000109-22-CZ
• Lead Sponsor: Fakultní nemocnice Hradec Králové

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified