community-acquired pneumonia, hospital-acquired pneumonia MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10076918 Term: Hospital acquired pneumonia System Organ Class: 100000004862
Conditions
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal to or above 18 years 2. Male or female gender 3. In case of women of reproductive age, willingness to use dual contraceptive method during the study period 4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member State where the trial is planned 5. Community-acquired pneumonia or hospital-acquired pneumonia 6. qSOFA score equal to 1 7. Serum presepsin > 350 pg/ml Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Age below 18 years • Denial of written informed consent • Any stage IV malignancy • Any do not resuscitate decision • Patients with PaO2/FiO2 less than 150 necessitating non-invasive ventilation or mechanical ventilation • Hospitalization in Intensive Care Unit • Known hypersensitivity to anakinra • Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days • qSOFA score 0, 2 or 3 • Any anti-cytokine biological treatment for the last one month • Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study • Participation in any other interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The INSPIRE study is an exploratory, randomised, phase IIa clinical trial which aims to evaluate the potential benefit of presepsin-guided anakinra therapy as an adjuvant to the standard of care treatment in patients with community-acquired pneumonia or hospital-acquired pneumonia by preventing the development of organ dysfunction as defined by changes in SOFA score by day 7.;Secondary Objective: Not applicable;Primary end point(s): ?he progression into organ dysfunction. This is a composite endpoint. Patients who meet any of the following are considered to meet this endpoint: i) increase of SOFA score by 2 or more points from day 1 (before start of the study drug) until day 7; ii) death by day 90.;Timepoint(s) of evaluation of this end point: Day 7 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change of SOFA score over all days of follow-up •Incidence of specific organ dysfunction by day 28 •Time until discharge from hospital •Mortality by day 28 •Mortality by day 90 •Time until attenuation of sepsis-induced inflammation as defined by PCT measurements •Change of presepsin from baseline until day 10 •Comparison of change of cytokine function and endothelial dysfunction markers from baseline by days 4 and 7 •Comparative progression into organ dysfunction (defined as in the primary endpoint) between patients who failed screening because of presepsin 350 pg/ml or less and patients who were enrolled in the study and were allocated to Treatment Arm 1 •Comparative 28-day mortality between patients who failed screening because of presepsin 350 pg/ml or less and patients who were enrolled in the study and were allocated to Treatment Arm 1;Timepoint(s) of evaluation of this end point: Days 4, 7, 10, 28, 90 and by hospital discharge | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed