E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
diabetic patients with soft tissue infection, necessiting antibiotic therapy |
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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 |
1) Determination of concentrations of linezolid in plasma and the ISF of inflamed tissue and non-inflamed s.c. tissue of diabetes patients after a single dose. Tissue concentrations will be related to corresponding unbound plasma concentrations. 2) Determination of concentrations of linezolid in plasma and the ISF of inflamed tissue and non-inflamed s.c. tissue of diabetes patients after multiple doses. Tissue concentrations will be related to corresponding unbound plasma concentrations. 3) To explore, if there is an influence of inflammation on tissue pharmacokinetics of linezolid. 4) Calculation of pharmacokinetic/pharmacodynamic indices to estimate target site efficacy of linezolid.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female, ≥ 18 years old • Diagnosis of Diabetes mellitus • Clinically diagnosed skin or STI and/or infected ulcers of the leg, requiring antimicrobial therapy • Prescription of antibiotic indicated, with Linezolid being an adequate therapy. • Willingness and ability to comply with the protocol • Signed informed consent
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E.4 | Principal exclusion criteria |
• Allergy or hypersensitivity against study drug. • Severe renal impairment, defined by a serum creatinine level > 1.6 mg/L • Severe hepatic impairment ( Child-Pugh Class C) • Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period • Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
The time versus unbound linezolid concentration profiles in the ISF of inflamed tissue and non-inflamed subcutaneous adipose tissue and in plasma of diabetes patients after multiple doses will be determined. The following PK parameters will be determined for all compartments. Main outcome variables: Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2), time of maximum concentration (tmax). Secondary outcome variables: ratios of AUC and Cmax of different compartments (inflamed vs. non-inflamed, plasma vs. tissue), time above minimum inhibitory concentrations of linezolid for susceptible bacteria (T>MIC), ratio of Area under the concentration vs. time curve form 0 to 24 hours (AUC0-24)/MIC.
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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 | 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 | 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 | 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 | |
E.8.9.1 | In the Member State concerned days | |