E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Infections that are either related to orthopedic surgery or simply affects the bones |
|
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 | 10019095 |
E.1.2 | Term | Hallux Valgus correction |
E.1.2 | System Organ Class | 100000004865 |
|
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 this trial is to asses the penetration of cefuroxime into muscle, subcutaneous and bone tissue using the pharmacokinetic tool microdialysis, and to see how the use of torniquete affects the penetration and the ischaemic markers. The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers. Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, Tmax and AUC). |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed informed consent - Age ≥ 18 years - Normal distal blood preasure bilateral - Normal kidney numbers - Fertile women have to use safe contraception. |
- Underskrevet informeret samtykke. - Planlagt fodoperation i Ortopædkirurgisk regi ved Hospitalsenheden Horsens. - Alder ≥ 18 år. - Normalt distalt blodtryk bilateralt. - Normale nyretal. - Fertile kvinder skal anvende sikker anti-conception.
|
|
E.4 | Principal exclusion criteria |
- Previouse surgery of the arteries in the leg (concerns both legs) - Previouse surgery of the calcaneus (concerns both legs) - Previouse bone infections or fracture of the calcaneus (concerns both legs) - Diabetes - unsuccessful spinal anaesthesia - Allergy to cefuroxime |
- Tidligere arteriel karkirurgi i benet (gælder i begge ben). - Tidligere kirurgi i calcaneus (gælder i begge ben). - Tidligere fraktur eller knogleinfektion i calcaneus (gælder i begge ben). - Diabetes. - Mislykket anlæggelse af spinalblok. - Allergi for cefuroxim.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, Tmax and AUC). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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 | 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
|
|
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 | |