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Avibactam

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.

Table of Contents

Overview of the Avibactam trials

The trial data show several Phase 3 studies that include Avibactam, often as part of ceftazidime-avibactam research.[1][2][4] These studies are focused on serious infections, treatment strategy, and antibiotic dosing in high-risk patients.[1][3]

Most of the research is interventional, which means patients receive a planned treatment or treatment strategy and the results are then measured.[1][5] The studies are authorised and include large and small groups, from 14 patients to 1,486 patients.[2][7]

Patient groups studied

The target populations are mostly patients with severe or life-threatening infections or patients who are critically ill.[3][4] These include people with Pseudomonas aeruginosa bacteremia, severe infections, sepsis, bloodstream infection, ventilator-associated pneumonia, hospital-acquired pneumonia, and pyogenic liver abscess.[1][5][6][7]

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.[2] 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.[7]

Trial designs and phases

All of the listed studies are in Phase 3, which is a later stage of clinical research.[1][2][3][4][5][6][7] Phase 3 studies usually compare treatment options or strategies in larger patient groups to learn how useful the approach is in real clinical care.[1][5]

Some trials compare different antibiotic durations, while others compare treatment delivery methods, antibiotic selection strategies, or dosing plans.[1][4][5][6] This means the research is not only about the medicine itself, but also about how best to use it in sick patients.[2][3]

Main outcomes and endpoints

The studies measure outcomes such as mortality, treatment failure, antibiotic exposure, and clinical improvement.[1][5][6][7] In one trial, the main outcome is the number of days on antibiotics and the DOOR scale category at day 30 after treatment ends.[1]

Another trial measures pharmacokinetic parameters, PK/PD target attainment, and whether an optimised dosing regimen can be developed.[2] A different study measures the number of days patients receive broad-spectrum antibiotics, and another checks antibiotic plasma targets in critically ill patients.[3][4]

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.[1][7]

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.[1] It includes 306 patients and is authorised as a Phase 3 interventional trial.[1]

2023-505536-35-00 looks at the dosing of ceftazidime-avibactam in critically ill patients receiving continuous renal replacement therapy.[2] 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.[2]

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.[3] Avibactam is listed among the intervention drugs in this trial.[3]

2024-516232-10-00 aims to describe whether critically ill patients reach the planned antibiotic blood levels for several drugs, including ceftazidime-avibactam.[4] The main endpoint is antibiotic PK/PD plasma target attainment.[4]

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.[5] The study includes 600 patients and is also a Phase 3 interventional trial.[5]

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.[6] This is a Phase 3 non-inferiority trial with 456 patients.[6]

NCT05979545 evaluates early therapy decisions with ceftazidime-avibactam through rapid diagnostic testing in bloodstream infection, ventilator-associated pneumonia, and hospital-acquired pneumonia.[7] Its main endpoint is a composite of all-cause mortality and lack of improvement in SOFA score at day 14 after the index culture.[7]

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.[1][5][7] 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.[1][3][4]

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.[2][4][7]

Trial ID Phase Condition studied Status Enrollment
NCT05210439 Phase 3 Pseudomonas aeruginosa bacteremia Authorised 306
2023-505536-35-00 Phase 3 Ceftazidime-avibactam therapy in critically ill patients on continuous renal replacement therapy Authorised 14
2022-502962-26-00 Phase 3 Severe infections Authorised 190
2024-516232-10-00 Phase 3 Serious infections in critically ill patients treated with antibiotics Authorised 1250
NCT05681442 Phase 3 Sepsis Authorised 600
2025-520940-14-00 Phase 3 Pyogenic liver abscess Authorised 456
NCT05979545 Phase 3 Bloodstream infection, ventilator-associated pneumonia, hospital-acquired pneumonia Authorised 1486

FAQ

  • What are clinical trials of Avibactam trying to find out? They are mainly checking how Avibactam is used in infection studies, especially in combination treatment. The trials look at outcomes such as treatment success, survival, and how well dosing works in different patient groups.
  • Who may take part in these trials? The target groups include critically ill patients, people with severe infections, patients with bloodstream infection, sepsis, pneumonia, and pyogenic liver abscess. Some studies also focus on patients receiving continuous renal replacement therapy.
  • What phases are the Avibactam trials in? The trials listed here are all Phase 3 studies. Phase 3 means the treatment or strategy is being tested in larger groups to learn more about how well it works and how safe or useful it is in real patients.
  • What kinds of results are measured in these studies? The studies measure outcomes such as mortality, treatment failure, days on antibiotics, clinical improvement, and drug levels in the blood. Some trials also use special scoring systems like SOFA or DOOR/RADAR.
  • Are these trials only about Avibactam alone? No. Several studies look at Avibactam as part of ceftazidime-avibactam, while others study antibiotic strategies that include Avibactam among other options. The focus is on the clinical trial question, not only on one medicine by itself.

Ongoing Clinical Trials on Avibactam

  • Study on Optimizing Ceftazidime-Avibactam Dosing for Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Spain Sweden

  • Study on the Effectiveness and Safety of 7 vs. 14 Days of Antibiotic Treatment with Meropenem for Patients with Pseudomonas Aeruginosa Blood Infection

    Recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Evaluating ceftazidime and avibactam with rapid testing for patients with bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Italy

  • Study comparing 3-week versus 6-week antibiotic treatment for patients with drained pyogenic liver abscess

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study of antibiotic treatment effectiveness in critically ill patients receiving drug combination therapy

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study Comparing Different Antibiotic Treatments for ICU Patients with Hospital-Acquired Sepsis: Focus on Cefepime and Drug Combination

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Avibactam and Drug Combination for Treating Severe Infections in Patients

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

Glossary

  • Phase 3: A later stage of clinical research in which a treatment is tested in larger groups of patients to see how well it works and to gather more safety information.
  • Interventional study: A study where researchers give a treatment or compare different treatment plans and then measure the results.
  • Bacteremia: Bacteria in the blood. This can be serious and may need hospital treatment.
  • Pseudomonas aeruginosa: A type of bacteria that can cause difficult infections, including bloodstream infection and pneumonia.
  • Critically ill: Very sick patients who need close monitoring, often in an intensive care unit.
  • Continuous renal replacement therapy: A slow form of kidney support used in very sick patients whose kidneys are not working well.
  • Pharmacokinetics: How the body handles a medicine, including how it moves through the blood and tissues.
  • PK/PD target attainment: A measure of whether the drug level in the body reaches the level thought to be needed for effect.
  • SOFA score: A score used in very sick patients to track organ failure and how severe the illness is.
  • DOOR/RADAR: A way to rank treatment results by combining benefits and harms into one outcome measure.
  • Non-inferiority trial: A study designed to show that one treatment is not worse than another by more than a small allowed amount.
  • Treatment failure: When the infection does not improve as expected or comes back after treatment.

References