Measurements of the antimicrobial vancomycin in subcutaneous tissue and bone tissue using microdialysis

Phase 1

• Conditions: Orthopedic infections; MedDRA version: 17.1Level: LLTClassification code 10050155Term: Knee prosthesis insertionSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-000258-12-DK
• Lead Sponsor: Orthopedic Research in Aarhus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-12
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

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

Inclusion Criteria

- The patients must be scheduled for a knee prosthesis. The indication must be arthrosis
-Normal kidney function. Serum creatinine must be within the range of 60 – 100 µmol/l.
- Male gender
- The patients must be competent
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Allergy to cefuroxime og vancomycin
- Ongoing treatment with vancomycin
- Female gender

Study & Design

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