E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgical ICU patients with severe infection and renal replacement therapy |
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E.1.1.1 | Medical condition in easily understood language |
Surgical ICU patients with severe infection and renal replacement therapy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
The aim of the present study is to assess the pharmacokinetics of tigecycline in patients with acute renal failure receiving continuous veno-venous hemodialysis (CVVHD) with regional citrate anticoagulation or continuous veno-venous hemodiafiltration (CVVHDF) with conventional heparin-based anticoagulation. Particularly, the following parameters should be evaluated:
• Area under the concentration-time curve from 0 to 12 h (AUC0-12) in 8 patients each receiving CVVHD (citrate anticoagulation) or CVVHDF (heparin anticoagulation and predilution), respectively. • Comparison of these AUC0-12 data with the values described in previous population kinetics. • Total elimination half-life of tigecycline under CVVHD and CVVHD
All measurements will be taken under steady state conditions (on day 4 or later of intra-venous tigecycline treatment with an initial single dose of 100 mg iv and 50 mg iv b.i.d) after starting CVVHD or CVVHDF for at least 24 hours. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Male and female patients * Indication for Tigecycline therapy based on suspected/diagnosed infection * Patients with acute renal failure and renal replacement therapy (CVVHD of CVVHDF)
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E.4 | Principal exclusion criteria |
* Pregnant women * breastfeeding mother * Age > 75 years * liver failure * Comedication with warfarin * Known allergies to antibiotics of the tetracycline group |
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E.5 End points |
E.5.1 | Primary end point(s) |
AUC of tigecycline during renal replacement therapy in comparison to published pharamkokinetic data in healthy adults |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood concentration 0, 1 h, 1,25 h, 1,5h, 1,75 h, 2 h, 4 h, 6 h, 8 h und 12 h after start of Tigecyclin-infusion during renal replacment therapy |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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
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The trial will be finished when data collection of the pharmacokinetics of tigecycline in 8 patients during renal replacement therapy (CVVHD and CVVHDF respectively) will be completed. |
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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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |