AuthorisedTherapeutic exploratory (Phase II)Interventional

A prospective, multinational, multicenter, randomized, sequential, double-blind, placebo-controlled, phase 2a clinical study to assess the safety and pharmacokinetics (PK) of OMN6 in hospital-acquired bacterial pneumonia (HABP) or ventilated-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

This study is looking into a new medicine, OMN6, to treat serious lung infections called pneumonia. These infections are often caught in hospitals or by patients on breathing machines. The specific type of pneumonia this study is focused on is caused by a germ called Acinetobacter baumannii complex. Researchers want to see if OMN6 is safe and how it moves through and leaves the body. Half the patients will receive OMN6, and the other half will get a salt water solution (placebo), so doctors can compare the effects. They will closely monitor for any side effects and see how patients respond to the treatment. This will help doctors understand if OMN6 could be a helpful new treatment for these challenging infections.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Omnix Medical Ltd.

Enrolment target

Start

06 May 2026

Hospital-acquired bacterial pneumonia or ventilated-associated bacterial pneumonia caused by Acinetobacter baumannii complex.

What is this study about?

Imagine you're in the hospital, perhaps recovering from an operation or a serious illness, and you develop a severe lung infection called pneumonia. Or maybe you're on a breathing machine, and that's where the infection starts. These infections can be very serious, especially when caused by certain germs that are hard to treat.

This study is testing a new medicine, code-named OMN6, specifically for these tough lung infections – known as hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). The main germ they're targeting is called Acinetobacter baumannii complex. Doctors need new ways to fight these infections because they can be very challenging to treat with current medicines.

The main goal is to find out if OMN6 is safe for people to use and to understand how the body handles it. They also want to see if it helps patients get better. By comparing OMN6 to a simple salt water solution (a 'placebo'), researchers can get a clear picture of how effective the new medicine is.

Key takeaways

This study is for very serious lung infections caught in hospitals.
It tests a new medicine called OMN6 for a specific challenging germ.
The main goals are to check safety and how the body handles OMN6.
Participants will receive either OMN6 or a salt water placebo.
You'll get very close medical monitoring if you take part.
You can stop participating at any time you wish.

Who may be eligible?

To join this study, you would need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also take part.

The most important requirement is that you must have one of the specific types of lung infection being studied: pneumonia caught in a hospital (HABP) or pneumonia that developed while you were on a breathing machine (VABP).

Crucially, this pneumonia must be caused by a particular germ called Acinetobacter baumannii complex. Doctors will do tests to confirm you have this specific infection before you can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have pneumonia that you caught in a hospital?
Did you get pneumonia while on a breathing machine?
Has a doctor confirmed your pneumonia is caused by the germ Acinetobacter baumannii complex?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new medicine (OMN6) or a salt water solution (placebo) through a drip. Neither you nor your doctors would know which one you are getting. Throughout the study, medical staff would closely monitor your health, looking for any changes or side effects.

This would involve regular check-ups, blood tests, and heart tracings (ECGs). Doctors would also keep an eye on your vital signs like temperature and blood pressure. They would specifically check how well your body is fighting the infection and how you are feeling. The study would last for a specific period, and after receiving the medicine, you would have follow-up visits or checks for about 28 days to see how you are doing in the long term, including your overall survival.

Potential risks and benefits

Taking part in a study like this might offer a chance to receive a new medicine that could help treat your serious infection, especially if standard treatments aren't working well. You would also receive very close medical attention and monitoring. However, there are potential risks, as OMN6 is a new medicine, and its full effects and side effects are still being investigated. You might experience side effects from the medicine, or it might not work for your infection. Half the participants will get a placebo, which means they won't be receiving the active study medicine. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Hungary
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Unverified
Greece

Common questions

What is HABP or VABP?

These are serious lung infections (pneumonia) that people can get when they are in hospital (HABP) or when they are on a breathing machine (VABP).

What is 'Acinetobacter baumannii complex'?

This is a specific type of germ or bacteria that can cause these serious lung infections and is often hard to treat.

What does 'double-blind' mean?

It means that neither you nor your doctors will know if you are receiving the new medicine (OMN6) or the salt water solution (placebo). This helps make the study fair.

What is a 'placebo'?

A placebo in this study is a salt water solution, which looks exactly like the study medicine but has no active drug in it. It's used for comparison.

Will I get better if I join this study?

Researchers hope the new medicine might help, but there's no guarantee. You might get OMN6 or a placebo, and doctors will closely watch your health regardless.