CompletedPhase 2

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

United States, Belgium, France150 participantsStarted 2024-02-02

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Refractory septic shock. * Not expected to survive 72 hours. * Hospital-acquired or ventilator-associated pneumonia or known or suspected pneumonia due to aspiration or other physical injury or trauma or tuberculosis. * Known or suspected hypersensitivity to AON-D21 or any components of the formulation used (e.g., PEG, mannitol or EDTA) or a history of clinically relevant allergy requiring continuous treatment, or of anaphylaxis. * Known fibrotic lung disease, bronchiectasis or any other known severe chronic respiratory disease. * Active malignant disease. * Factors other than a pathogen suspected or conf…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events.

Timeframe: 28 days.

Trial details

NCT IDNCT05962606

SponsorAptarion Biotech AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-16

View on ClinicalTrials.gov More Community-acquired Pneumonia trials