In short
Clinical trials investigating Avibactam are studying its use in infection-related research, often as part of ceftazidime-avibactam treatment. These studies look at safety, treatment response, dosing, and outcomes in patients with severe infections, bloodstream infection, pneumonia, sepsis, and critically ill patients. Most trials are Phase 3 studies.
Key points
- Clinical trials involving Avibactam are focused on serious infections and on how antibiotic treatment is used in very sick patients. Most studies are Phase 3 and include patients with Pseudomonas aeruginosa bacteremia, sepsis, pneumonia, pyogenic liver abscess, or critical illness with kidney support. Some trials study ceftazidime-avibactam dosing or antibiotic exposure, while others compare treatment strategies and outcomes like mortality, treatment failure, or days on antibiotics. Several trials also use special measures such as SOFA score, DOOR/RADAR, and PK/PD targets. The overall goal is to learn which treatment approach gives the best results in these high-risk patient groups.
Overview of the Avibactam trials
The trial data show several Phase 3 studies that include Avibactam, often as part of ceftazidime-avibactam research. These studies are focused on serious infections, treatment strategy, and antibiotic dosing in high-risk patients.
Most of the research is interventional, which means patients receive a planned treatment or treatment strategy and the results are then measured. The studies are authorised and include large and small groups, from 14 patients to 1,486 patients.
Patient groups studied
The target populations are mostly patients with severe or life-threatening infections or patients who are critically ill. These include people with Pseudomonas aeruginosa bacteremia, severe infections, sepsis, bloodstream infection, ventilator-associated pneumonia, hospital-acquired pneumonia, and pyogenic liver abscess.
One study is aimed at critically ill patients receiving continuous renal replacement therapy, which is a form of kidney support used in very sick patients. Another large study focuses on patients with infections due to Pseudomonas aeruginosa or carbapenemase-producing Enterobacterales, which are bacteria linked to difficult-to-treat infections.
Trial designs and phases
All of the listed studies are in Phase 3, which is a later stage of clinical research. Phase 3 studies usually compare treatment options or strategies in larger patient groups to learn how useful the approach is in real clinical care.
Some trials compare different antibiotic durations, while others compare treatment delivery methods, antibiotic selection strategies, or dosing plans. This means the research is not only about the medicine itself, but also about how best to use it in sick patients.
Main outcomes and endpoints
The studies measure outcomes such as mortality, treatment failure, antibiotic exposure, and clinical improvement. In one trial, the main outcome is the number of days on antibiotics and the DOOR scale category at day 30 after treatment ends.
Another trial measures pharmacokinetic parameters, PK/PD target attainment, and whether an optimised dosing regimen can be developed. A different study measures the number of days patients receive broad-spectrum antibiotics, and another checks antibiotic plasma targets in critically ill patients.
Some studies use special tools such as the SOFA score, which tracks organ failure, and DOOR/RADAR, which ranks outcomes by balancing benefit and harm.
What each key trial is studying
NCT05210439 studies whether 7 days of antibiotic treatment is better than 14 days for bacteremia caused by Pseudomonas aeruginosa, using a DOOR/RADAR analysis at day 30 after treatment. It includes 306 patients and is authorised as a Phase 3 interventional trial.
2023-505536-35-00 looks at the dosing of ceftazidime-avibactam in critically ill patients receiving continuous renal replacement therapy. Its goal is to describe drug exposure and build a population PK model, which is a mathematical way to study how medicine behaves in groups of patients.
2022-502962-26-00, called the MODIFY trial, studies whether a procalcitonin-guided and molecular-guided strategy can reduce the number of days patients receive broad-spectrum antibiotics in severe infections. Avibactam is listed among the intervention drugs in this trial.
2024-516232-10-00 aims to describe whether critically ill patients reach the planned antibiotic blood levels for several drugs, including ceftazidime-avibactam. The main endpoint is antibiotic PK/PD plasma target attainment.
NCT05681442 compares 30-day mortality in patients with hospital-acquired sepsis in the ICU according to the mode of administration of the main beta-lactam antibiotic, and Avibactam is listed among the interventions. The study includes 600 patients and is also a Phase 3 interventional trial.
2025-520940-14-00 studies antibiotic duration after drainage of pyogenic liver abscess and asks whether 3 weeks is non-inferior to 6 weeks for treatment failure at week 12. This is a Phase 3 non-inferiority trial with 456 patients.
NCT05979545 evaluates early therapy decisions with ceftazidime-avibactam through rapid diagnostic testing in bloodstream infection, ventilator-associated pneumonia, and hospital-acquired pneumonia. Its main endpoint is a composite of all-cause mortality and lack of improvement in SOFA score at day 14 after the index culture.
What these studies mean for patients
For patients, these trials are mainly asking which treatment plan works best in serious infections and in very sick hospitalised people. The studies also try to find the best length of treatment and the best way to give antibiotics so patients may get the right amount of treatment without unnecessary exposure.
Because the trial data are focused on serious infections, the results are most relevant to hospital patients, especially those in intensive care or with complex infection problems.