E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053840 |
E.1.2 | Term | Bacterial sepsis |
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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 demonstrate that the study drug treatment of patients with severe sepsis results in a reduction in 28 day all cause mortality compared to placebo treatment. |
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E.2.2 | Secondary objectives of the trial |
To confirm the safety and tolerability of the study drug. 3. To demonstrate that the study drug treatment of patients with severe sepsis results in long-term 3 months, 6 months, 12 months survival benefit. 4. To determine the effect of the study drug treatment on the duration of ICU and overall hospital stay. 5. To perform pharmacoeconomic and quality of life analyses of treatment with study drug |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male and female subjects Aged 18 years Objective evidence of bacterial or fungal infection A confirmed early onset severe sepsis, as defined by SIRS and qualifying organ dysfunction QOD . Baseline APACHE II score of 21 to 37 12 hours since onset of QOD Weight 150 kg A commitment to full patient support |
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E.4 | Principal exclusion criteria |
Pregnancy or breast feeding Extensive third degree burns 20 BSA Patients whose death to sepsis is considered imminent Patients not expected to survive at least 2 months due to a pre-existing and uncorrectable medical condition or those in a chronic vegetative state or other chronic neurological condition associated with thought impairment Patients currently receiving immunosuppressive therapy Patients with granulocyte counts 1000/mm unless the decreased count is believed to be due to sepsis Patients that required cardiopulmonary resuscitation in the 4 weeks prior to evaluation for enrollment Patients HIV-positive with CD4 count 50/mm within 4 weeks of enrollment or end-stage processes e.g. systemic M. avium infection, progressive multifocal leukoencephalopathy Patients with significant hepatic impairment Child-Pugh Class C , portal hypertension or esophageal varices Patients who are expected to be treated with endotoxin-removal devices Patients must not have taken any investigational medications ie, not approved by FDA or other national agencies for any indication within the 30-day period prior to enrollment into the study. IL-2 or IL-6 therapy within 30 days prior to enrollment |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate that the study drug treatment of patients with severe sepsis results in a reduction in 28 day all cause mortality compared to placebo treatment. |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |