AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3 prospective, randomized, multicenter, active-controlled study to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B compared with colistin plus high-dose ampicillin/sulbactam in the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex

This research study is for adults in hospital who have a severe lung infection called pneumonia. This particular type of pneumonia is caused by bacteria that are very difficult to treat with standard antibiotics. The study is comparing a new treatment combination, BV100 alongside a lower dose of polymyxin B, with a common treatment combination (colistin and ampicillin/sulbactam). Doctors want to find out which treatment is more effective at helping patients recover and if the new combination has fewer side effects. We hope this research will lead to better ways of treating these serious infections, especially for patients who are on breathing machines.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bioversys S.A.S.

Enrolment target

Start

10 Jun 2026

Hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex

What is this study about?

This study is a Phase 3 clinical trial, which means it's a large, important step in testing new medicines. Doctors are looking for better ways to treat a specific type of serious lung infection called hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia. These infections are particularly concerning because they are caused by a germ called Acinetobacter baumannii-calcoaceticus complex, which has become resistant to many common antibiotics, sometimes called 'carbapenem-resistant'. This makes them very challenging to treat.

The main goal of this research is to compare a new experimental treatment with a standard treatment. The new treatment involves a medication called BV100 given together with a lower dose of polymyxin B. This is being compared against the standard treatment, which uses colistin and a higher dose of ampicillin/sulbactam. Doctors will carefully monitor how well each treatment works to clear the infection and if patients recover well. They will also be looking closely at any side effects or unwanted reactions to the medicines.

Ultimately, by comparing these two treatment approaches, the study aims to find out if the new combination of BV100 and polymyxin B is more effective, safer, or both, for these very difficult-to-treat lung infections. This could potentially offer new hope for patients who have limited treatment options when battling these serious bacterial illnesses.

Key takeaways

This study is for adults with severe, hard-to-treat lung infections caught in hospital.
It compares a new medicine combination with a standard treatment.
The goal is to find more effective and safer ways to treat these resistant infections.
You will be closely monitored for treatment effects and side effects.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, participants must be adult patients, aged 18 or older. Both men and women can take part in the research. The key requirement is that you must be in hospital and have a confirmed diagnosis of a serious lung infection.

Specifically, this lung infection must be hospital-acquired pneumonia or ventilator-associated pneumonia, meaning it developed while you were in hospital or on a breathing machine. Most importantly, the infection must be caused by a particular type of bacteria (called Acinetobacter baumannii-calcoaceticus complex) that has become resistant to common antibiotics.

Patients will be carefully checked by the study doctors to make sure they meet all the necessary health criteria for safety and to ensure the study results are clear. This will involve looking at your medical history and current health status.

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?
Are you currently in hospital with a lung infection?
Has your doctor told you that your lung infection is pneumonia that you caught in hospital or while on a breathing machine?
Has your doctor confirmed that your infection is caused by 'carbapenem-resistant Acinetobacter' bacteria?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of two treatment combinations as chosen randomly by a computer – either the new study medicine (BV100 with polymyxin B) or the standard treatment (colistin with ampicillin/sulbactam). Both treatments are given through a drip into your arm.

Your health will be closely monitored throughout the study. This will involve regular checks of your vital signs like blood pressure, heart rate, and temperature. You will also have blood and urine tests, and potentially heart recordings (ECGs), to check how you are responding to the treatment and to look for any side effects. Doctors will also track any other medicines you are taking.

The study will follow your progress for at least 28 days to see how well the treatment works and if the infection clears. There will be specific assessments on days 3, 5, 8, at the end of treatment, and at follow-up visits. The safety of the treatments will be continuously assessed.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits. You might receive a new treatment that could be more effective for your severe infection, or you might help doctors learn more about the best ways to treat similar conditions in the future, helping others. However, like all medicines, both the new treatment and the standard treatment can have side effects or risks. Study doctors and nurses will carefully explain these and monitor you closely. Participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Greece

Common questions

What kind of infection is this study looking at?

It's looking at serious lung infections (pneumonia) that patients get in hospital, especially those caused by bacteria that are very hard to treat with regular antibiotics.

What are 'carbapenem-resistant' bacteria?

These are bacteria that have become very strong and are no longer killed by a type of powerful antibiotic known as carbapenems, making them difficult to treat.

What is a 'Phase 3' study?

A Phase 3 study is a large research trial that compares a new treatment with an existing standard treatment to confirm if it is safe and effective before it can be widely used.

Will I know which treatment I'm getting?

This study is 'randomised', meaning a computer will decide which treatment you receive. This helps ensure the study results are fair and unbiased.

How long does the study last?

Your progress will be followed for at least 28 days to see how well the treatment works and to monitor your recovery.