E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Orthopedic infections. |
ortopædkirurgiske infektioner. |
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E.1.1.1 | Medical condition in easily understood language |
Infections that are either related to orthopedic surgery or simply affects the bone. |
Infektioner som er relateret til ortopædkirurgiske indgreb eller infektioner lokaliseret i knoglen. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043658 |
E.1.2 | Term | Thumb osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 |
The objectives of the trial are to asses the penetration of cefuroxime when it is administered as either a single administration or as repeated administration, into bone, synovial sheath, and subcutaneous tissue with the use of the pharmacokinetic sampling method, micro dialysis. The primary endpoints are the time for which the concentration of cefuroxime is above the minimal inhibitory concentration (T>MIC) and penetration ratios. The secondary endpoints are standard pharmacokinetic parametres such as; half-life, Cmax, Tmax and AUC.
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Formålet med dette studie er at undersøge penetrationen af cefuroxim til knogle- og senevæv samt subcutis, når det administreres hhv. én eller to gange, sidstnævnt med et doseringsinterval på 4 timer. Dette undersøges vha. mikrodialyse. De primære endepunkter er tiden, hvor koncentrationen af cefuroxim ligger over minimal inhibitory concentration (T>MIC) samt penetrations ratioer. Sekundære endepunkter er farmakokinetiske parametre så som: halveringstid, Cmax, Tmax og AUC. |
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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 |
- signed informed consent - age minimun 18 years - elective trapeziectomy at the Department of Orthopedic Surgery, Aarhus University Hospital - Normal liver- and kidney numbers - Fertile women have to use safe contraception. Fertile women, who do not use safe contraception will have to perform a urin-hCG. |
- Underskrevet informeret samtykke. - Planlagt trapezektomi på Ortopædkirurgisk Afdeling, Aarhus Universitetshospital. - Alder minimum 18 år. - Normale nyre- og levertal præoperativt. - Fertile kvinder skal anvende sikker anti-konception præoperativt. Fertile kvinder, som ikke anvender sikker anti-konception vil få foretaget graviditetstest ved hCG-urinstix.
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E.4 | Principal exclusion criteria |
- Allergy towards antibiotics from the group of beta-lactams (penicillins, cephalosporins, and carbapenems) - Diabetes - Previous surgery of the 1. metacarp (concerns the operated hand) - Previous fracture of the 1. metacarp (concerns the operated hand) - Previous surgery of the arteries in the arm (concerns the operated hand) - Treatment with cefuroxime 4 days prior to the surgery |
- Allergi for antibiotika fra beta-laktam gruppen (penicilliner, cephalosporiner og carbapenemer). - Diabetes. - Tidligere kirurgi i 1. metacarp (gælder den side der skal opereres). - Tidligere fraktur i 1. metacarp (gælder den side der skal opereres). - Tidligere arteriel karkirurgi i armen (gælder den side der skal opereres). - Behandling med cefuroxim de 4 forudgående dage før operationen.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are the time for which the concentration of cefuroxime is maintained above til minimal inhibitory concentration (T>MIC) and penetration ratios. |
De primære endepunkter er den tid, hvor koncentrationen af cefuroxim er over minimal inhibtory concentration (T>MIC) og penetrationsratioer. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Endpoints will be evaluated at the end of the study. |
Endepunkterne vil blive evalueret vil studiets ende. |
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E.5.2 | Secondary end point(s) |
Standard pharmacokinetic parametres: half life, Cmax, Tmax, and AUC. |
Standard farmakokinetiske parametre: halveringstid, Cmax, Tmax og AUC. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoints will be evaluated at the end of the study. |
Endepunkterne vil blive evalueret vil studiets ende. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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.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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
cefuroxime in other dose. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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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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 | 9 |
E.8.9.1 | In the Member State concerned days | |