E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study population will consist of a representative group of adult male or female patients with documented diabetes and bacterial soft tissue infection of the foot complicated by osteomyelitis. Patients must be subjected to undergo surgical debridement and intravenous antimicrobial therapy. |
|
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 evaluate the pharmacokinetic profile of linezolid in inflamed subcutaneous adipose tissue in diabetic foot infection at steady state after twice daily intravenous administration of 600 mg. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the pharmacokinetic profiles of linezolid in non-inflamed subcutaneous adipose tissue, bone and plasma
- To compare the pharmacokinetic profiles of inflamed soft tissue, healthy soft tissue, bone and plasma |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent to participate in the study 2. Male or female patient of 18 years of age or older 3. Patient suffers from documented diabetes and soft tissue infection of the lower limb complicated by osteomyelitis 4. Patient requires surgical debridement with bone resection and intravenous anti-microbial therapy 5. Negative urine pregnancy test in females of childbearing potential 6. Patient is willing to participate in the study, follow protocol study treatment regimen, and comply with all planned assessments.
|
|
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 (Appendix 4). 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 submitted to the hospital with known pathogens resistant to study drug 10. Use of any other investigational therapy at the time of enrolment, or within 30 days. 11. Patients unable or unwilling to adhere to the study-designated procedures and restrictions. 12. Unable to understand the nature, purpose and extent of the study 13. Breast-feeding woman
|
|
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
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
| 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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |