E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hyperaggregability of thrombocytes triggered by severe infection (i.e. pneumonia or invasive urinary tract infection or a cutaneous infection). |
- Primaire klinische diagnose luchtweginfectie/longontsteking Of - Primaire klinische diagnose urineweginfectie OR - Primaire klinische diagnose huidinfectie
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E.1.1.1 | Medical condition in easily understood language |
Blood platelet activity in patients with pneumonian, or a invasive urinary tract infection, or a skin infection |
De plakkerigheid van bloedplaatjes in patiënten met een luchtweg-, urinweg- of huidinfectie. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 |
Measuring the efficacy of aspirin in inhibiting platelet activity in patients during (recovery from) a severe infection. |
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E.2.2 | Secondary objectives of the trial |
• Measuring the ‘natural’ course of platelet activity in patients with a severe infection. • Registry of cardiovascular events within 90 days after the onset of a severe infection.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ASPIRIN-CVD-TRIAL, 14th of May 2019, • To assess the influence of an infectious state on aspirin’s efficacy to inhibit platelet activity in patients with stable cardiovascular disease. |
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E.3 | Principal inclusion criteria |
In order to be eligible to participate in the main-trial, a subject must meet all of the following criteria: Primary clinical diagnosis of pneumonia OR Primary clinical diagnosis of invasive urinary tract infection OR Primary clinical diagnosis of cutaneous infection AND 18 years or older on the date of hospital presentation AND Hospitalization for at least 24 hours AND Having received at least 1 dose of antibiotics within 48 hours of admission.
In order to be eligible to participate in the sub-study, a subject must meet all of the following criteria: Primary clinical diagnosis of pneumonia OR Primary clinical diagnosis of invasive urinary tract infection OR Primary clinical diagnosis of cutaneous infection AND 18 years or older on the date of hospital presentation AND Hospitalization for at least 24 hours AND Having received at least 1 dose of antibiotics within 48 hours of admission AND Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months). AND Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months). |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in the main-trial: - Active metastatic cancer (c.q. malignancy) - Allergy to salicylate - Platelet count <120*109/l - History of non-traumatic major bleeding - Known bleeding diathesis - Conditions which require antiplatelet therapy - Usage of antiplatelet therapy - Surgery 1 month prior to diagnosis - Currently pregnant - Chronic usage of medication which are known to influence platelet function other than antibiotics (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
A potential subject who meets any of the following criteria will be excluded from participation in the sub-study: - Active metastatic cancer (c.q. malignancy) - Platelet count <120*109/l - History of non-traumatic major bleeding - Known bleeding diathesis - Surgery 1 month prior to diagnosis - Currently pregnant - Chronic usage of medication which are known to influence platelet function other than antibiotics or aspirin (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort) |
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E.5 End points |
E.5.1 | Primary end point(s) |
PFA-200 parameters: closure time, flow slope, maximum rate of occlusion and area under the curve TBX2 serum levels.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
On three different time frames after the diagnosis of a severe infection: - Day 3 after the first day of the hospitalization (prior to randomization) - Day 14 after the first day of the hospitalizatoin - >Day 90 after the first day of the hospitalizatoin |
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E.5.2 | Secondary end point(s) |
Platelet- , reticulated platelet- , leucocyte count and haemoglobin level |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
On three different time frames after the diagnosis of a severe infection: - Day 3 after the first day of the hospitalization (prior to randomization) - Day 14 after the first day of the hospitalizatoin - >Day 90 after the first day of the hospitalizatoin |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |