BV100 drug combination for treating adult patients with hospital‑acquired and ventilator‑associated pneumonia caused by carbapenem‑resistant Acinetobacter baumannii

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What is this study about?

hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex is a serious lung infection that can develop after a stay in the hospital, especially for patients on a breathing machine. The trial compares two ways to treat this infection: one uses the experimental drug BV100 together with a low dose of polymyxin B, and the other uses the established antibiotic colistin combined with a high dose of ampicillin/sulbactam. The purpose of the study is to determine which regimen works better at treating the infection, which is also referred to as a CRABC infection.

Participants will be randomly assigned (by chance, similar to flipping a coin) to receive one of the two treatment combinations by intravenous infusion, meaning the medication is given through a vein. The treatment lasts several days, after which patients are followed for up to 28 days to see if the infection clears and to monitor safety. Doctors will check vital signs such as blood pressure, heart rate, and temperature, perform routine laboratory tests, and record any side effects that occur during the study.

1 randomization

after you join the study, you will be assigned by the study staff to one of two treatment groups. the assignment is done randomly, so you will receive either the bv100 plus low dose polymyxin b regimen or the colistin plus high dose ampicillin/sulbactam regimen.

2 start of study medication

on the first day after randomization, the study medication will be started.

if you are in the bv100 group, you will receive bv100 (dose not specified in the source) together with low dose polymyxin b at a dose of 1 million iu (international units) given by intravenous infusion.

if you are in the comparator group, you will receive colistin at a dose of 13.5 million iu given by intravenous infusion together with high dose ampicillin/sulbactam (ampicillin sodium and sulbactam sodium) at a dose described as 9 df dosage form given by intravenous infusion.

3 daily medication administration

the assigned medication will be given each day by intravenous infusion. the infusion is usually performed once per day, but the exact schedule will follow the protocol defined by the study physician.

the infusion time and any additional fluids will be managed by the clinical team.

4 clinical assessments

your clinical condition will be evaluated at several time points:

day 3, day 5 and day 8 after the start of treatment, the study staff will check for signs of clinical cure (improvement of pneumonia symptoms).

at the end of treatment (eot), a test of cure (toc) will be performed, and finally an end of study (eos) visit will occur.

each assessment will include a physical exam, measurement of temperature, blood pressure and heart rate, and review of any symptoms.

5 safety monitoring

throughout the treatment period, safety will be monitored continuously.

vital signs (blood pressure, heart rate and body temperature) will be recorded regularly.

blood samples will be taken for laboratory tests that include chemistry, blood counts and urinalysis.

kidney function will be checked, and electrocardiograms (ekg) may be performed to evaluate heart rhythm.

any adverse events (side effects) you experience will be documented.

6 treatment duration and discontinuation

treatment will continue for the period determined by the study protocol, typically up to 14 days, unless the physician decides to stop earlier because of clinical improvement or safety concerns.

7 follow‑up for mortality outcome

after the last dose of study medication, you will be followed for up to 28 days to record survival status (28‑day all‑cause mortality).

additional follow‑up visits may be scheduled to collect information on any late‑appearing side effects.

Who Can Join the Study?

Informed consent: You must sign a written agreement to join the study, or a legally authorized representative may sign for you if needed. If you regain consciousness while in the study, you will need to read, understand, and agree to continue.
Age range: You must be between 18 and 82 years old at the time you sign the consent form.
You must have a confirmed diagnosis of hospital‑acquired pneumonia (HABP) or ventilator‑associated pneumonia (VABP) that requires treatment with intravenous antibiotics, as decided by your doctor.
You need a high likelihood that the pneumonia is caused by a specific resistant bacteria called carbapenem‑resistant Acinetobacter baumannii‑calcoaceticus complex (CRABC). This must be shown by a rapid diagnostic test (RDT) done on a breathing sample (such as sputum or a small fluid sample from the lungs). In addition, you must meet one of the following:
- You have received only a short, specified amount of previous antibiotics that work against CRABC before the first dose of the study drug.
- Your condition is getting worse or not improving after at least 48 hours of prior antibiotic treatment.
You must have a health‑status score that shows you are not too critically ill: an APACHE II score less than 30 or a quick Sequential Organ Failure Assessment (qSOFA) score of 2 or higher, measured within 24 hours before screening.
If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use a highly effective birth‑control method (such as condoms, birth‑control pills, implant, injection, intrauterine device, or a partner who has had a vasectomy) from the time of screening until at least 30 days after the last study dose. If you only use birth‑control pills, you must also use a barrier method like a condom.
You must be diagnosed with HABP or VABP according to the study’s detailed definition (essentially the same condition described in item 3).
If you do not qualify for Part A, you may still join Part B if you meet any of the following additional requirements:
- The infection is caused by CRABC that is resistant to the drugs colistin or polymyxin B (shown by a lab measurement called MIC ≥ 4 mg/L).
- For these resistant infections, you must have laboratory proof of the bacteria and either:
  - Received only a short, specified amount of an antibiotic that the CRABC is still sensitive to before the first study dose, or
  - Shown clear signs that previous treatment with colistin or polymyxin B failed (your condition worsened or did not improve) after a specified period of treatment.

Who Cannot Join the Study?

Infection resistant to colistin (a medicine) or known intolerance to polymyxin drugs, or taking any medication that would stop you from receiving polymyxins.
Liver enzymes called AST or ALT more than three times the normal limit together with total bilirubin (a waste product) more than twice normal, or severe chronic liver disease (called Child‑Pugh Class C). (Small acute rises up to five times are allowed if they are clearly caused by the infection.)
Significant heart test findings such as new reduced blood flow to the heart, a heart attack, dangerous fast heart rhythm, very slow heart rate that cannot be fixed with a pacemaker or medication, or a history of the most severe heart failure (NYHA Class IV) within the past year.
Unable to provide a proper lung sample for testing – the sample must show very few squamous cells and enough white blood cells (polymorphonuclear neutrophils) to be useful.
Abnormally long heart electrical interval called the QTc (greater than 500 ms) confirmed by a repeat test.
Stroke (either blockage or bleeding in the brain) within the last 10 days, or expected to survive less than 28 days after a stroke, or a very low consciousness score (Glasgow Coma Scale 3) with no chance of improvement.
Women who are pregnant or breastfeeding.
Currently taking part in another experimental drug or device study, or have done so within the past 30 days (or five drug half‑lives, whichever is longer), or receiving other experimental treatments.
Received a long period of prior antibiotics that are active against the target bacteria before the first study dose, unless the prior antibiotics were ineffective for the infection or were used for other reasons (such as gut decontamination).
Must continue taking any of these medicines during the study: probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium.
Known or suspected allergy to polymyxin, rifabutin, colistin, ampicillin/sulbactam, meropenem, or any of their inactive ingredients.
Patients judged by the medical team to have no realistic chance of benefit (futility of care) or who live permanently in long‑term care facilities and are receiving only comfort or palliative care.
Acute severe graft‑versus‑host disease (grade 3 or higher).
Having another active lung infection at the same time that needs extra antibiotics (for example, caused by common bacteria, viruses, fungi, or atypical organisms).
Any of the following serious health conditions:
- Severe lung disease that prevents measuring a treatment response (such as lung cancer blocking airways, active tuberculosis, cystic fibrosis, fungal lung infection, lung abscess, pleural empyema, post‑obstructive pneumonia, or ongoing COVID‑19 infection without improvement).
- Pleural empyema unless it can be drained within 24 hours and treated within two weeks.
- Organ transplant (kidney, liver, etc.) performed within the last six months.
- Deep infections like bone infection or meningitis that need long‑term therapy (unless the infection is drained and cleaned).
- Acute bacterial infection of the heart valves (endocarditis) that requires urgent surgery or makes surgery too risky.
- Surgical wound infections that need additional surgery.
- Peritonitis (infection of the abdominal lining).
- Permanent implanted device or line that is thought to be the source of the infection.
- Known or suspected nerve or muscle disease.
- HIV infection.
- Long‑term weakened immune system from medicines or disease (such as severe combined immunodeficiency, lupus, active chemotherapy, or azathioprine).
Bronchial blockage or a past episode of post‑obstructive pneumonia (this does not apply to chronic COPD).
Unable or unwilling to follow all study procedures as required.
Persistent shock with low blood pressure that needs strong medicines called vasopressors to keep average arterial pressure at 65 mmHg or higher, especially if blood lactate is rising, unless only a very low dose of norepinephrine (< 1 µg/kg/min) is being used for a specific reason.
Diagnosis of ventilator‑associated tracheobronchitis (infection of the airway while on a breathing machine).
Need for any additional systemic antibiotic that works against the target bacteria (CRABC) at the time of randomization or likely during the study.
Expected to survive less than 72 hours or having a Do‑Not‑Resuscitate (DNR) order.
Severe burns covering more than 40 % of the body surface.
Low neutrophil count (a type of white blood cell) less than 1,500 per mm³ at screening or expected to become that low.
Severe kidney disease defined as an estimated glomerular filtration rate (eGFR) under 30 mL/min/1.73 m², or needing dialysis, or producing less than 20 mL of urine per hour over 24 hours.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Klinički bolnički centar Zagreb (University Hospital Center Zagreb)	Zagreb	Croatia
Kat Attica General Hospital	Kifissia	Greece

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Klinika Za Infektivne Bolesti Dr. Fran Mihaljevic	Zagreb	Croatia
Lhvfb Gwdiwzm Hdiluupn Om Azbkqx	Athens	Greece
Kkkmiftt bwywsrkl ctvzsx Rzwfld (dkhuvclg Hlmmldpk Cxhqnk Rvsjimn	Rijeka	Croatia

Trial status

Country	Status	Recruitment Start
Croatia	Not yet recruiting	10.06.2026
Greece	Not yet recruiting	10.06.2026

Trial locations

Investigated drugs:

BV100 is an experimental medication being studied for the first time in people. It is given by an IV drip and is designed to fight infections caused by a very resistant type of bacteria that can cause pneumonia in hospitals. In this trial, BV100 is combined with a low amount of another antibiotic to see if it can safely clear the infection.

Polymyxin B sulfate is an existing antibiotic that is given through an IV infusion. It works by attacking the outer layer of certain tough bacteria, helping to kill them. In the study, a low dose of Polymyxin B is used together with BV100 to treat the resistant lung infection.

Colistin is a well‑known antibiotic used for serious infections caused by hard‑to‑treat bacteria. It is also given by IV infusion. In this trial, colistin is used as a comparison treatment, combined with a higher dose of another drug, to see how it performs against the new therapy.

Ampicillin and sulbactam (often called ampicillin/sulbactam) is a combination of two medicines that work together: ampicillin kills bacteria, while sulbactam stops the bacteria from breaking down ampicillin. This combo is given by IV infusion, sometimes with a small amount of lidocaine to reduce pain from the injection. In the study, it is given at a high dose together with colistin as the standard treatment arm.

Rifabutin is an antibiotic that is usually used to treat infections caused by certain bacteria. It is administered by IV infusion in this trial. Rifabutin is being tested as another possible treatment option for the resistant pneumonia, allowing researchers to compare its safety and effectiveness with the other medicines.

Investigated diseases:

Pneumonia bacterial

Hospital-acquired bacterial pneumonia – Hospital-acquired bacterial pneumonia is an infection of the lung that develops at least 48 hours after a patient is admitted to a hospital. It often occurs in people who are on a ventilator, which can let bacteria enter the airways. The illness usually starts with cough, fever, and shortness of breath, and the infection spreads within the lung tissue, causing inflammation and fluid buildup. As the bacteria multiply, breathing becomes more difficult and oxygen levels may drop. If the bacterial load continues to increase, the inflammation can involve larger areas of the lung.

Trial ID:

2025-524092-23-00

Protocol code:

BV100-010

NCT ID:

NCT07326540

Trial Phase:

Therapeutic confirmatory (Phase III)

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BV100 drug combination for treating adult patients with hospital‑acquired and ventilator‑associated pneumonia caused by carbapenem‑resistant Acinetobacter baumannii

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?