Pharmacokinetica of Cefuroxime

Phase 1

• Conditions: hip or knee replacement or spine bone surgery; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2016-001511-20-DE
• Lead Sponsor: Institute for Pharmacology and Toxicology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

We will include patients (women and men) from 40 to 80 years which are, for clinical reasons, undergoing a hip replacement or knee replacement therapy or spine surgery in the participating center. The patients must be able to understand and sign informed consent that the patient is willing to participate in the study. The patients must be legally competent. The patients must have signed the consent form.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients who are unable to consent will not be included in the study. Patients who have retracted their consent will not be included in the study.
Based on the literature, cephalosporine can be used in pregnancy. For safety reasons premenopausal women will be excluded from this trial. This will be ascertained by clinical examination, asking whether she is pregnant, asking the patient about her last visit to her gynaecologist and the result of this consultation; a urine test of pregnancy will be performed and evaluated before a decision on surgery is made. No elective orthopaedic surgery will be done in pregnant women.
We will exclude patients with the relevant and accompanying diseases like:
Known allergy against cefuroxime or another member of the group of cephalosporines from anamnestic information.
Known severe hypersensitivity against a member of the group of beta-lactam antibiotics (like penicillines, carbopenemes or monobactames) from anamnestic information.
Prior traumatic surgery in the previous six months, past or present osteomyelitis, impaired function of the heart ( > NYHA II), impaired function of the liver (relevantly high GOT-value, patients having values more than double the upper normal value of the clinical laboratory for GOT), high body mass index (BMI > 35).
Patients with anemia, children and young adults that are still growing, breast-feeding women.
Patients with leucocytopenia.

Patients with thrombocytopenia.
Patients taking at admission to the hospital diuretics (e.g. frusemide) or aminoglycoside antibiotics.
Patient with candida infections on admission.
Patients with colitis at admission.
Patients with abdominal infections.
Patients with impaired renal function at admission, which is a creatinine clearance below 20 ml/min (see summary of product characteristics: Cefuroxim-ratiopharm p.i.).

Study & Design

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