E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 antibiotics |
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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 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 β-lactame-antibiotics
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E.4 | Principal exclusion criteria |
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 β-lactame-antibiotics
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E.5 End points |
E.5.1 | 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.
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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 1 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |