E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Morbi-mortality in critically ill patients is linked to vitamin D deficiency. Moreover, vitamin D deficiency has been related to inappropriate response to infection (due to vitamin D involvement in immunity signaling pathways, including response to pathogens). Recent data about critically ill patients suggest that the lowest range of vitamin D status seems to benefit from cholecalciferol supplementation. |
Morbi-mortality in critically ill patients is linked to vitamin D deficiency. Moreover, vitamin D deficiency has been related to inappropriate response to infection (due to vitamin D involvement in immunity signaling pathways, including response to pathogens). Recent data about critically ill patients suggest that the lowest range of vitamin D status seems to benefit from cholecalciferol supplementation. |
|
E.1.1.1 | Medical condition in easily understood language |
Morbi-mortality in critically ill patients is linked to vitamin D deficiency. Moreover, vitamin D deficiency has been related to inappropriate response to infection. |
Morbi-mortality in critically ill patients is linked to vitamin D deficiency. Moreover, vitamin D deficiency has been related to inappropriate response to infection. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
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 |
Impact of survival rate at D30 |
Impact of survival rate at D30 |
|
E.2.2 | Secondary objectives of the trial |
Impact of survival rate at D90, ∆SOFA, vasopressor-free days at D30 , intensive care unit-free days, antibiotics-free days, ventilation-free days, ventilatory acquired pneumoniae, catheter related infection, bacteremia, composite endpoint including. |
Impact of survival rate at D90, ∆SOFA, vasopressor-free days at D30 , intensive care unit-free days, antibiotics-free days, ventilation-free days, ventilatory acquired pneumoniae, catheter related infection, bacteremia, composite endpoint including. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients hospitalized in ICU for sepsis who are more than 18 years old, insured under a French social security system, with a ∆SOFA≥2, 25(OH)D<20 ng/mL are eligible for study participation. |
Patients hospitalized in ICU for sepsis who are more than 18 years old, insured under a French social security system, with a ∆SOFA≥2, 25(OH)D<20 ng/mL are eligible for study participation. |
|
E.4 | Principal exclusion criteria |
Pregnant or breastfeeding women; hypercalcemia, tuberculosis; sarcoidosis; nephrolithiasis within the prior year, and patients not deemed suitable for study participation (i.e., psychiatric disease, living remotely from the clinic, or prisoner status). |
Pregnant or breastfeeding women; hypercalcemia, tuberculosis; sarcoidosis; nephrolithiasis within the prior year, and patients not deemed suitable for study participation (i.e., psychiatric disease, living remotely from the clinic, or prisoner status). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Survival rate at D30 |
Survival rate at D30 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study |
End of study |
|
E.5.2 | Secondary end point(s) |
Survival rate at D90, ∆SOFA, vasopressor-free days at D30 , intensive care unit-free days, antibiotics-free days, ventilation-free days, ventilatory acquired pneumoniae, catheter related infection, bacteremia, composite endpoint including [death, ventilatory acquired pneumonia, catheter infection, bacteremia] |
Survival rate at D90, ∆SOFA, vasopressor-free days at D30 , intensive care unit-free days, antibiotics-free days, ventilation-free days, ventilatory acquired pneumoniae, catheter related infection, bacteremia, composite endpoint including [death, ventilatory acquired pneumonia, catheter infection, bacteremia] |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study |
End of study |
|
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 | Yes |
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) | 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.8.2.4 | 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 | 2 |
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
|
Survival rate at D90 with phone contact with the patient |
Survival rate at D90 with phone contact with the patient |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |