E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10040054 |
E.1.2 | Term | Sepsis, bacteraemia, viraemia and fungaemia NEC |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Measure in vivo neuroinflammation |
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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 |
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E.4 | Principal exclusion criteria |
• Pregnancy or wish to become pregnant within 2 weeks after PET-CT scan.
• Contra-indication to undergo a CT or MRI scan, including claustrophobia.
• Unstable hemodynamics or respiration that contra-indicate transport and undergoing PET/MRI imaging.
• Other causes not related to sepsis that sufficiently explain (relation in time) the onset of delirium such as newly onset severe kidney or liver failure, or severe electrolyte disturbances, severe hypoglycaemia.
• Delirium coinciding with start of medications known to increase the risk of development of delirium. This will be judged by the delirium expert: e.g. neurologist, geriatrician, or senior delirium researcher (e.g. based on the type of drug known to trigger delirium and the temporal relationship between start of the medication and onset of delirium).
• Presence of delirium before onset of infection.
• Age < 50 years.
• Moribund patients or patients on palliative care.
• Brain or spinal surgery within the last 3 months.
• Meningitis or brain infection within the 6 months.
• Pre-existing cognitive impairment interfering with the ability to understand informational material about this research project.
• Presence of a CSF catheter or shunt.
• Patients with known brain tumours.
• Patients with brain injury (e.g. acute stroke, brain trauma, or subarachnoid haemorrhage) within the last 3 months.
• Chronic (>6 weeks) use of immunosuppressive agents.
• Concomitant diseases resulting in severe immunosuppression (e.g. HIV).
• Chronic use of neuroleptics, defined as pre-hospital use.
• Patients that do not speak Dutch or have disabilities that prevent accurate delirium diagnosis.
• Analphabetic patients.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2 weeks after onset of sepsis |
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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 |
3, 6, 12 months follow-up |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.3 |
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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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 | 0 |