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
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Community-acquired pneumonia, confirmed or suspected of bacterial or viral origin.
• Admitted to an ICU (or similar unit).
• Requiring respiratory support by HFO ≥ 30 L/min with FiO2 ≥ 30% or NIV or IMV or ECMO.
• CRP ≥ 50 mg/L.
• PaO2/FiO2 ratio ≤ 150 mmHg.
• Treatment initiation no more than 48 h after initiation of respiratory support (HFO ≥ 30 L/min with FiO2 ≥ 30%, NIV, IMV or ECMO).
• Written informed consent.
• Age ≥ 18 years to ≤ 85 years.
• Body mass index ≥ 17.5 kg/m² and ≤ 40 kg/m².
• For female participants of childbearing potential, agreement to use dual methods of contraception until Day 60.
• For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 60 and to refrain from donating sperm during the study and for 3 months after the last infusion.
Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Clinique Saint Pierre
RECRUITING
Ottignies
France
Centre Hospitalier Argenteuil
RECRUITING
Argenteuil
Centre Hospitalier Départemental Vendée
RECRUITING
La Roche-sur-yon
CHU Dupuytren
RECRUITING
Limoges
Centre Hospitalier de Melun
RECRUITING
Melun
Hotel Dieu - CHU Nantes
RECRUITING
Nantes
Assistance Publique-Hopitaux de Paris (AP-HP)
RECRUITING
Paris
Nouvel Hôpital Civil
RECRUITING
Strasbourg
CHRU de Tours Hôpital Bretonneau
RECRUITING
Tours
Hôpital Nord Franche Comté
RECRUITING
Trévenans
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Cologne-Merheim Hospital Lung Clinic
RECRUITING
Cologne
University Hospital Cologne
RECRUITING
Cologne
Universitaetsklinikum Giessen und Marburg GmbH
RECRUITING
Giessen
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Doctor Josep Trueta
RECRUITING
Girona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitari Mútua Terrassa
RECRUITING
Terrassa
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
United Kingdom
University Hospital Bristol and Weston NHS
RECRUITING
Bristol
University Hospital of Wales
RECRUITING
Cardiff
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
University College London
RECRUITING
London
University Hospitals Plymouth NHS Trust, Derriford Hospital
RECRUITING
Plymouth
Royal Berkshire Foundation Trust
RECRUITING
Reading
Mid Yokshire Teaching NHS Trust
RECRUITING
Wakefield
York Hospital
RECRUITING
York
Contact Information
Primary
Antonio Perez, MD
perez@aptarion.com
+49-30-959 982-140
Backup
Axel Vater, PhD
vater@aptarion.com
+49-30-959 982-140
Time Frame
Start Date:2024-02-02
Estimated Completion Date:2026-06-30
Participants
Target number of participants:150
Treatments
Experimental: AON-D21 plus Standard of Care
Sterile liquid formulation of AON-D21 in 4% mannitol + 0.05% EDTA in glass vials. It will be administered intravenously, for up to 10 days plus Standard of Care therapy for severe community-acquired pneumonia as per local guidelines.
Placebo_comparator: Placebo plus Standard of Care
Sterile liquid formulation of 5% glucose solution in matched glass vials with a 1.5 mL fill volume. It will be administered intravenously, for up to 10 days plus Standard of Care therapy for severe community-acquired pneumonia as per local guidelines.