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A study to evaluate the safety of OMN6 in patients with pneumonia caused by Acinetobacter baumannii bacteria.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Hospital-acquired bacterial pneumonia or Ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex. These are serious lung infections that develop after a person has been staying in a hospital or is using a breathing machine to help them breathe. The purpose of the study is to evaluate the safety and the pharmacokinetics, which describes how a drug moves through and is processed by the body, of an experimental medication called OMN6.

During the study, participants will receive either OMN6 or a placebo through an intravenous infusion, which is a method of delivering fluids directly into a vein. The study is designed to observe how the body responds to different doses of the medication over a single day of treatment. Researchers will monitor how the drug is absorbed and used by the body to determine its safety and how it can be best administered.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry and medication administration
You will receive either the test medication, called omn6, or a placebo, which is a saline solution. the placebo is a substance that contains no active medicine.
The omn6 is provided as a powder for infusion in a dose of 450 mg. the saline is provided in a dose of 714.3 ml.
Both the omn6 and the saline are delivered through an intravenous infusion, which means the liquid is put directly into a vein.
Step 2
Treatment duration and monitoring
The treatment is administered for a single day.
During the study, vital signs, such as blood pressure and heart rate, and ecgs, which are tests that record the electrical activity of the heart, are monitored.
clinical laboratory findings, which are tests performed on blood or other bodily fluids, are used to check your health status.
Your body's response to the medication is tracked to determine how the drug moves through your system, a process known as pharmacokinetics.
Step 3
Follow-up period
Monitoring continues for a period of 28 days to observe any changes in health or adverse events, which are unexpected medical occurrences.

Who can join the trial?

11 criteria

You must sign a signed informed consent form, which is a document that explains the study and shows you agree to participate.
You must be 18 years of age or older at the time you sign the consent form.
You must have hospital-acquired pneumonia (a lung infection caught during a hospital stay) or ventilator-associated pneumonia (a lung infection caused by using a breathing machine) caused by a specific type of bacteria called Acinetobacter baumannii complex.
You must be receiving certain background antibiotic therapies, which are standard medicines used to fight infection, such as Meropenem, Ampicillin/Sulbactam, or Colistin.
Your estimated glomerular filtration rate (eGFR), which is a measure of how well your kidneys are filtering waste from your blood, must be greater than 30 ml/min (specifically, different groups have different requirements between 30 and 50 ml/min or above 50 ml/min).
Women who are able to become pregnant must have a negative serum pregnancy test (a blood test showing no pregnancy) within 72 hours before being assigned to a study group.
Women who can become pregnant must agree to use a highly effective method of contraception (a reliable way to prevent pregnancy) throughout the study.
Men with female partners who can become pregnant must agree to use barrier methods of contraception (such as condoms) and must not donate sperm during the study.
Your APACHE II score (a tool used to measure how sick a patient is) must be between 10 and 24, or your SOFA score (a tool used to measure how much organs are failing) must be between 5 and 10.
If you were not treated in an intensive care unit, your quick SOFA (qSOFA) score (a simplified version of the organ failure tool) must be 2 or higher.
A chest X-ray or CT scan (imaging tests used to look inside the chest) must show new or worsening infiltrates, which are areas in the lungs that show signs of infection or fluid.

Who cannot join the trial?

18 criteria

People with liver dysfunction, which means blood tests show abnormal levels of liver enzymes (such as AST, ALT, or alkaline phosphatase), high levels of bilirubin (a yellow substance in the blood), or a low platelet count (cells that help blood clot).
People with immunosuppression, which means a weakened immune system caused by a medical condition or medicine. This includes people undergoing chemotherapy (cancer treatment), those who have had a bone marrow or stem cell transplant, those taking drugs to prevent organ rejection, or those using long-term systemic corticosteroids (strong anti-inflammatory medicines).
Anyone for whom the Investigator (the main doctor in charge of the study) believes participating would be unsafe or would make the study results unreliable.
People who have used another investigational drug (a medicine being tested in a study) or medical device within the last 30 days.
People with an active infection from other types of Gram-negative bacteria (a specific category of bacteria) that are resistant to all BAT (combination antibiotic therapy) options.
People who require any extra antibiotic treatments other than the specific BAT being studied to treat their pneumonia.
People who need other medicines that are known to react poorly with BAT, which could cause safety issues.
People who have infections in other parts of their body that require antibiotics to treat Gram-negative pathogens (harmful bacteria) other than those targeted by the study treatment.
People whose life expectancy is expected to be less than 48 hours.
Women who are pregnant (carrying a developing baby) or are breastfeeding.
People in septic shock, which is a severe condition where a body-wide infection causes dangerously low blood pressure that requires medicine to keep the blood flowing to organs, and high levels of lactate (a byproduct of metabolism) in the blood.
People who received BAT treatment for more than 24 hours straight during a specific window of time before the study starts.
People with a known hypersensitivity (an allergic reaction) to certain antibiotics like Ampicillin/Sulbactam, Colistin, carbapenems, or other β-lactams (a group of antibiotics).
People with pneumonia caused by things other than the specific bacteria being studied, such as community-acquired pneumonia (infection caught in daily life), viral pneumonia (caused by a virus), or chemical pneumonia (caused by inhaling harmful substances).
People with a coinfection (having two infections at once) caused by life-threatening molds like aspergillosis or mucormycosis.
People with an infection in the central nervous system, which includes the brain and spinal cord, such as meningitis (inflammation of the membranes covering the brain).
People with lung diseases that would make it impossible to see if the treatment is working, such as lung cancer, tuberculosis, cystic fibrosis, or a lung abscess (a pocket of infection in the lung).
People with neutropenia, which is a condition where there are very few neutrophils (a type of white blood cell that helps fight infection) in the blood.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Alexandra Hospital
Athens, Greece
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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

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Investigated drugs

OMN6 is an experimental medicine being tested to see if it is safe and how it moves through the body in patients with specific types of lung infections caused by bacteria. It is given directly into a vein through an infusion.

Saline

What is already known about the treatment

Saline
This substance is a simple saltwater solution administered through an intravenous infusion into the bloodstream. It is widely used in medicine as a neutral substance that has no active medicinal effect, making it an ideal placebo for clinical studies. It does not treat specific diseases but serves to maintain fluid balance in the body.
OMN6
This medication is provided as a powder that is mixed with liquid and given directly into a vein through an infusion. It is currently being studied in clinical trials to determine if it can effectively treat serious lung infections caused by specific bacteria. As a test substance, it is designed to target and destroy harmful bacteria at a molecular level to stop the infection from spreading.

Investigated diseases

Hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex - This is a lung infection that develops in individuals while they are staying in a hospital setting. It can specifically occur in patients who are using a machine called a ventilator to help them breathe. The infection is triggered by a group of bacteria known as the Acinetobacter baumannii complex. The disease progresses as the bacteria multiply within the respiratory tract, leading to inflammation and infection in the lung tissue.