Use of Presepsin as a Marker for Immunotherapy Administration in Pneumonia

• Status: Recruiting
• Trial end date: 2024-03-06
• Target enrollment: 0
• Participant gender: All

Summary

The current study is an exploratory, phase IIa randomized clinical trial (RCT) aiming to evaluate if early presepsin increase coupled with early initiation of anakinra as an adjunct therapy to the standard-of-care treatment may improve outcomes of community-acquired pneumonia or hospital-acquired pneumonia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Age equal to or above 18 years

• Male or female gender

• In case of women of reproductive age, willingness to use dual contraceptive method during the study period

• 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

• Community-acquired pneumonia or hospital-acquired pneumonia

• qSOFA score equal to 1

• Serum presepsin > 350 pg/ml

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