E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hip or knee replacement or spine bone surgery |
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E.1.1.1 | Medical condition in easily understood language |
replacement of hip joint or knee joint or surgery of spine for orthopedic reasons (e.g. chronic pain, dysfunction) |
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E.1.1.2 | Therapeutic area | Body processes [G] - Microbiological Phenomena [G06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
bone and plasma concentration of cefuroxime |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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.).
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Clinical Endpoint is the discharge of the present from the hospital.
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.
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 Cefuroxime before hip replacement surgery is started.
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E.5.2 | Secondary end point(s) |
Drawing of final (number eight) from the cubital vein of the patient after skin incision (start of surgery). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
This is an open study. Patients and house officers are aware that the drug is used. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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replacement of hip. this occurs in the theatre during the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |