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Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

Community-acquired Pneumonia Clinical Trial

Official title:
An Exploratory, Multi-Centre, Interventional, Prospective, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of AON-D21 in Patients With Severe Community-Acquired Pneumonia.

Clinical Trial Summary

The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, in patients with severe community acquired pneumonia admitted to ICU (or similar unit). The main questions to answer are: - The safety and tolerability of AON-D21 vs placebo. - The efficacy of AON-D21vs placebo. - The pharmacokinetics of AON-D21. - The pharmacodynamics of AON D21. - To identify biomarkers for patient stratification and analyses in future trials.

Clinical Trial Description

This clinical trial will enroll 100 participants, randomized 2:1 (AON-D21:placebo). Participants diagnosed with severe community-acquired pneumonia of bacterial or viral origin requiring admission to an intensive care unit or similar setting, will receive either AON-D21 or placebo intravenous infusions for up to 10 days. In addition, participants will receive standard of care as per local guidelines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05962606
Study type Interventional
Source Aptarion Biotech AG
Contact Antonio Perez, MD
Phone +49-30-959 982-140
Email perez@aptarion.com
Status Recruiting
Phase Phase 2
Start date February 2, 2024
Completion date June 30, 2025
View Details
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