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Use of Presepsin as a Marker for Immunotherapy Administration in Pneumonia

NCT05785442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-31

No results posted yet for this study

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.

Conditions

  • Community-acquired Pneumonia
  • Hospital-acquired Pneumonia

Interventions

DRUG

Anakinra Prefilled Syringe

Anakinra 100 mg administration subcutaneously once daily for 10 days (at least 4 days)

DRUG

Placebo

0.67 ml N/S 0.9% w/v administration subcutaneously once daily for 10 days (at least 4 days)

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Evangelos Giamarellos-Bourboulis, MD, PhD · Hellenic Institute for the Study of Sepsis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2024-06-28
Completion
2024-06-28

Countries

  • Greece

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785442 on ClinicalTrials.gov