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.

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

• 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