E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To measure the time versus concentration profile of Amoxicillin and Clavulanacid in the interstitial space of infected lung tissue as the target site of infection following intravenous administration of Amoxicillin and Clavulanacid |
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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 |
Amoxicillin and Clavulanacid have been shown as sufficient treatment in case of severe pleural empyema in the perioperative phase of the disease.
Nevertheless, remnant thick pleural membranes at the mediastinum as well as pneumonic infiltration lead sometimes to recurrence of empyema. One of the reasons of recurrence may be that concentration of antibiotics at the target site, the infected lung and pleural membranes are not high enough to neutralize the pathogens. By applying a pharmacokinetic approach based on the measurement of free interstitial concentrations by microdialysis, the efficiency of these antibiotics to eradicate bacteria at the relevant target site will be tested in our study. This will lead to a better understanding for antibiotic potential in infected lung tissue and pleural membranes and may result in a rational dosing regimen.
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E.2.2 | Secondary objectives of the trial |
To measure the time versus concentration profile of Amoxicillin and Clavulanacid in serum, interstitial space of infected lung tissue and pleural membranes, following administration of Amoxicillin 2g and Clavulanacid 200 mg (2,2 g intravenous). |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with thoracic empyema treated by decortication and stable hemodynamic conditions, after informed consent will be included. Patients with pre-existent known drug allergy will be excluded. |
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E.4 | Principal exclusion criteria |
Allergy against study medication, Pregnancy, Coagulopathies, positive HIV-serology, positive Hepatitis-serology, Cortisol-medication, renal insufficiency. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To measure the time versus concentration profile of Amoxicillin and Clavulanacid in the interstitial space of infected lung tissue as the target site of infection following intravenous administration of Amoxicillin and Clavulanacid |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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End of the trial: when 12 patients are successfully included. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |