Azienda Ospedaliero Universitaria Pisana
Verified
Pisa, Italy
Not yet recruiting
Evaluating ceftazidime and avibactam with rapid testing for patients with bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia
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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 serious infections, including bloodstream infection (an infection in the blood), hospital-acquired pneumonia (a lung infection caught during a hospital stay), and ventilator-associated pneumonia (a lung infection that develops in patients using a breathing machine). These infections are caused by specific bacteria, namely Pseudomonas aeruginosa or carbapenemase producing Enterobacterales, which are types of germs that have developed strong defenses against many common medicines. The purpose of the study is to evaluate the effect of using a rapid diagnostic system alongside the medication ceftazidime-avibactam compared to standard care.
Participants in the study will receive either ceftazidime-avibactam through an intravenous infusion, which is a method of delivering medicine directly into a vein, or standard antibiotics. The standard treatment may include different types of medicines such as penicillins, tetracyclines, fluoroquinolones, or other beta-lactam antibacterials. The study will also use rapid laboratory methods to identify the specific bacteria more quickly than usual to help guide the choice of medicine.
During the course of the study, the health of the participants will be monitored to see how they respond to the different treatments. This involves checking for signs of improvement in organ function and tracking how long a person stays in the hospital or the ICU, which is a specialized intensive care unit for the most seriously ill patients. Researchers will also observe the time it takes for the bacteria to clear from the body and monitor for any potential side effects or changes in the bacteria's resistance to the drugs used.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- You must be an adult, which means you are 18 years of age or older.
- You are at risk of having an infection in your bloodstream (blood infection), hospital-acquired pneumonia (a lung infection caught while staying in a hospital), or ventilator-associated pneumonia (a lung infection caused by using a breathing machine).
- The infection must be caused by specific types of bacteria called Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales (bacteria that have become resistant to certain strong antibiotics).
- Alternatively, you can participate if your blood culture (a test used to check for bacteria in the blood) shows the presence of Gram-negative bacilli (a specific shape and type of bacteria that react a certain way to a laboratory stain).
- Alternatively, you can participate if you are suspected of having hospital-acquired pneumonia or ventilator-associated pneumonia and your respiratory samples (fluids taken from your lungs or airways) show Gram-negative bacteria when viewed under a microscope using a Gram stain (a method used to identify bacteria by their color).
- You must provide informed consent, which means you have been given all the study details and have signed a document agreeing to participate.
Who cannot join the trial?
9 criteria
- You are in refractory shock, which means your blood pressure is dangerously low and does not respond to treatment, or you have other comorbid conditions, which are additional health problems, that make it unlikely you will live longer than 48 hours.
- Your bloodstream infection, which is an infection in the blood, is believed to be caused by a vascular catheter (a thin tube placed in a vein), and the tube cannot be taken out.
- The medical treatment is not being given with the goal of curing the infection.
- You have an infection that requires prolonged antibiotic treatment lasting longer than two weeks.
- You are currently staying in a correctional facility, such as a prison.
- You have participated in this specific study within the last 60 days.
- You have taken an investigational drug (a medicine being tested in a study) within the last 30 days or within a specific timeframe related to how long that medicine stays in your body, known as half-lives.
- Your doctor decides that joining the study is not in your best interest for your health and well-being.
- You are pregnant or currently breastfeeding.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Azienda Unita Sanitaria Locale Di Bologna
VerifiedBologna, ItalyIRCCS Ospedale Policlinico San Martino
VerifiedGenoa, Italy
Trial locations
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Investigated drugs
Zavicefta is a combination antibiotic used to treat serious bacterial infections. It works by fighting specific types of bacteria that may be resistant to other common treatments.
The comparator group involves standard care using various types of antibiotics, which may include Penicillins, Fluoroquinolones, Tetracyclines, or other antibacterial combinations, administered through a vein to treat infections.
What is already known about the treatment
Ceftazidime/Avibactam - This medication is administered as an intravenous infusion to treat serious bacterial infections like bloodstream infections and pneumonia. It is a combination antibiotic used to fight hard-to-treat bacteria that have developed resistance to other drugs. The ceftazidime part works by preventing bacteria from building their cell walls, while the avibactam part protects the antibiotic by disabling the enzymes bacteria use to destroy it. This combination is classified as a beta-lactam antibiotic with a specialized inhibitor.
Investigated diseases
Bloodstream Infection - This is a condition where harmful bacteria enter the blood through various entry points in the body. Once in the blood, these germs can travel to different organs and tissues. The infection can lead to a widespread inflammatory response throughout the body. It often occurs when the body's natural defenses are weakened or bypassed.
Hospital-Acquired Pneumonia - This is a lung infection that develops in a person after they have been admitted to a healthcare facility for at least 48 hours. It occurs when bacteria or other germs reach the lungs, causing inflammation in the air sacs. The condition can lead to difficulty breathing and increased mucus production. It typically affects individuals who are already receiving medical care for other issues.
Ventilator-Associated Pneumonia - This is a specific type of lung infection that develops in people who are using a mechanical breathing machine. The presence of a breathing tube can allow germs to enter the lungs more easily. This causes inflammation and infection within the respiratory system. It is a common complication for patients requiring intensive care and mechanical ventilation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520067-13-00Protocol code22-002Estimated enrolment1 586 patients
sourced from the EU Clinical Trials Register and site verification
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