E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects who are scheduled to undergo elective open-chest lung surgery will be included in the study. |
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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 |
To assess the pharmacokinetic (PK) profile of linezolid and other currently approved antibiotics in the extracellular space fluid of infected lung and unaffected subcutaneous adipose tissue at steady-state conditions |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: • To determine free blood levels of linezolid and other currently approved antibiotics. Further, to correlate these levels to minimal inhibitory concentrations of clinically relevant bacteria. • To calculate relevant PK/pharmacodynamic (PK/PD) indices for the prediction of clinical and microbiological efficacy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent to participate in the study. 2. Conservative treatment options failed to work well 3. Male or female patient of 18 years of age or older. 4. Scheduled to undergo elective lung surgery 5. Suspected or proven severe bacterial infection 6. Severe sepsis according to ACCP/SCCP guidelines and criteria. 7. Negative urine pregnancy test in females of childbearing potential |
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E.4 | Principal exclusion criteria |
1. Treatment with the study drug within the past three weeks prior to study enrolment. 2. Relevant renal dysfunction indicated by a creatinine clearance ≤ 40 ml/min as determined by the Cockcroft-Gault equation using actual body weight. 3. Severe hepatic impairment defined by a serum AST ≥ 150. 4. Neutrophil count <1000/µl 5. Thrombocytopenia < 50 000 /µl 6. HIV, HCV or HBV infection. 7. History of hypersensitivity to the study drug or to drugs with similar chemical structures (oxazolidinones). 8. Treatment with antidepressants belonging to the class of selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenalin reuptake inhibitors (SNRIs) 9. Patients unable or unwilling to adhere to the study-designated procedures and restrictions. 10. Breast-feeding women 11. Treatment with medications that inhibit monoamine oxidases A or B in the past two weeks. 12. Patients with uncontrolled hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute state of confusion. 13. Treatment with serotonin reuptake inhibitors, tricyclic antidepressants or 5-hydroxytryptamine/serotonin1B/1D (5-HT1B/1D) agonists
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E.5 End points |
E.5.1 | Primary end point(s) | |
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.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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
other antibiotics prescribed by the investigator |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |