Pharmacokinetics of Cetriaxon in bone
- Conditions
- hip replacement
- Registration Number
- EUCTR2006-004445-42-DE
- Lead Sponsor
- Institut for Pharmacology and Toxicology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
We will include patients (women and men) from 40 to 65 years which are, for clinical reasons, undergoing a hip replacement therapy in the participating centre. The patients must be able to understand and sign informed consent that the patient is willing to participate in the study.
Women must be postmenopausal.
We will use only patients with no relevant and accompanying diseases like:
prior traumatic surgery
past or present osteomyelitis
impaired function of the heart ( > NYHA II)
impaired function of the kidney (creatinine > 1,5 mg/ml)
impaired function of the liver (high GOT-value)
high body mass index (BMI > 35)
allergy against cephalosporine
allergy against ß-lactame-antibiotics
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients who are unable to 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.
We will exclude patients with relevant and accompanying diseases like:
prior traumatic surgery
past or present osteomyelitis
impaired function of the heart ( > NYHA II)
impaired function of the kidney (creatinine > 1,5 mg/ml)
impaired function of the liver (high GOT-value)
high body mass index (BMI > 35)
allergy against cephalosporine
allergy against ß-lactame-antibiotics
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: bone and plasma concentration of antibiotics;Secondary Objective: does not apply;Primary end point(s): The potential benefit of the study could be the identification of criteria for the development of new antibiotics that would be better than the currently used for the prophylaxes of bone infection in patients. <br><br>The aim of the current application is a correlation between the time of application, the dosing and the plasma levels of Ceftriaxon in relation to its concentrations in sub regions of the hip. It is routine to apply Ceftriaxon before hip replacement surgery is started. <br>
- Secondary Outcome Measures
Name Time Method