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Clinical Trials/EUCTR2018-000109-22-CZ
EUCTR2018-000109-22-CZ
Active, not recruiting
Phase 1

Monitoring of efficacy of antibiotic prophylaxis in thoracic surgery - MONATPRO

Fakultní nemocnice Hradec Králové0 sites30 target enrollmentMay 2, 2018
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ConditionsAntibiotic prophylaxis in thoracic surgeryMedDRA version: 20.0 Level: LLT Classification code 10036894 Term: Prophylactic antibiotic therapy System Organ Class: 100000004865Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]
DrugsVulmizolinAzepo

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Antibiotic prophylaxis in thoracic surgery
Sponsor
Fakultní nemocnice Hradec Králové
Enrollment
30
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 2, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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