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Avibactam Sodium

Clinical trials of Avibactam Sodium are studying aztreonam-avibactam in young patients with serious gram-negative bacterial infections. These studies look at pharmacokinetics, safety, and tolerability in neonates, infants, and children with infections such as sepsis, urinary tract infection, pneumonia, and bloodstream infection.

Table of Contents

Trial overview

These studies are testing aztreonam-avibactam in children with serious gram-negative bacterial infections. Avibactam Sodium is part of the study medicine in these trials, and the research is focused on how the treatment performs in young patients with infections that need intravenous antibiotic treatment.[1][2]

Both trials are Phase 2 and are listed as Authorised.[1][2] Phase 2 studies are usually done after early testing and are meant to learn more about safety and how the treatment behaves in patients.[1][2]

Who can participate

One study includes neonates and infants younger than 9 months who have suspected or confirmed infections due to gram-negative bacteria.[1] The other study includes pediatric participants from 9 months to younger than 18 years with serious gram-negative bacterial infections.[2]

The target groups are hospitalized children who may have infections such as sepsis, bloodstream infection, urinary tract infection, pneumonia, or intra-abdominal infection.[1][2] These studies are not for healthy volunteers; they are for patients who already have serious infections and need treatment in hospital.[1][2]

What is being studied

The first study is evaluating aztreonam-avibactam in neonates and infants with infections such as sepsis, complicated urinary tract infection, bloodstream infection, hospital-acquired pneumonia, ventilator-associated pneumonia, and complicated intra-abdominal infection.[1]

The second study compares aztreonam-avibactam with best available therapy, which means the treatment choice judged best by the study team for that patient group.[2] This comparison is being done in children with serious gram-negative bacterial infections, including complicated intra-abdominal infection, complicated urinary tract infection, bloodstream infection, and hospital-acquired or ventilator-associated pneumonia.[2]

In both trials, the researchers want to learn how the medicine acts in the body and whether it is safe and tolerable in young patients.[1][2] Tolerability means how well patients can take the treatment without major problems that stop treatment.[1][2]

Outcomes being measured

The main results include pharmacokinetic measures, often called PK, such as clearance, maximum plasma concentration, area under the plasma concentration-time curve, and half-life.[1][2] These measures help show how much of the study medicine is in the blood and how the body removes it over time.[1][2]

Researchers also measure plasma concentrations of ATM and AVI on Day 1 and again at steady state, which means after the medicine has been given long enough for blood levels to become stable.[1][2]

Safety outcomes include adverse events, serious adverse events, adverse events that lead to stopping treatment, and adverse events that result in death.[1][2] The trials also check liver and kidney function tests before treatment, during treatment, and after treatment ends.[1][2]

Trial details by study

NCT06462235 is a Phase 2 interventional study in 52 hospitalized neonates and infants younger than 9 months.[1] It studies aztreonam-avibactam for suspected or confirmed gram-negative infections, with outcomes focused on PK and safety.[1]

NCT05639647 is a Phase 2 interventional study in 54 pediatric participants from 9 months to younger than 18 years.[2] It compares aztreonam-avibactam with best available therapy and measures PK, safety, and tolerability in serious gram-negative infections.[2]

The first study uses aztreonam-avibactam with metronidazole listed among the interventions, while the second study lists aztreonam-avibactam and several possible comparator treatments used as best available therapy.[1][2] The trial records do not provide final results in the data shown here.[1][2]

Key patient terms

Gram-negative bacteria are a group of bacteria that can cause serious infections and may be harder to treat in some cases.[1][2] Sepsis is a severe body response to infection that can be life-threatening.[1][2]

Complicated urinary tract infection means a urinary infection that is more serious or harder to treat than a simple infection.[1][2] Complicated intra-abdominal infection means an infection inside the belly that is more serious and may need hospital treatment.[1][2]

Hospital-acquired pneumonia is lung infection that starts during a hospital stay, and ventilator-associated pneumonia happens in a patient using a breathing machine.[1][2] Bloodstream infection means the infection has reached the blood.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT06462235 Phase 2 Serious gram-negative infections in neonates and infants younger than 9 months, including sepsis, cUTI, BSI, HAP/VAP, and cIAI Authorised 52
NCT05639647 Phase 2 Serious gram-negative infections in pediatric participants 9 months to younger than 18 years, including cIAI, cUTI, BSI, and HAP/VAP Authorised 54

FAQ

  • What are the clinical trials of Avibactam Sodium studying? They are studying aztreonam-avibactam in children with serious gram-negative bacterial infections. The main goals are to measure how the study medicine behaves in the body and to check safety.
  • Who can take part in these trials? One study includes neonates and infants younger than 9 months. The other study includes pediatric participants from 9 months to younger than 18 years.
  • What conditions are being studied? The trials include conditions such as sepsis, bloodstream infection, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired pneumonia, and ventilator-associated pneumonia.
  • What phase are these trials in? Both trials are Phase 2 studies. Phase 2 means the treatment is being studied in patients to learn more about safety and how well it may work.
  • What results are the researchers measuring? They are measuring pharmacokinetics, which means how the medicine is absorbed, handled, and removed by the body. They are also tracking adverse events, serious adverse events, and liver and kidney test results.

Ongoing Clinical Trials on Avibactam Sodium

  • Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Greece Hungary Spain

  • Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Greece Hungary Italy Slovakia Spain

Glossary

  • Phase 2: A study stage that looks more closely at safety and early signs of benefit in patients.
  • Interventional study: A trial where researchers give a study treatment and then measure the results.
  • Pharmacokinetics (PK): How the body absorbs, moves, breaks down, and removes a medicine.
  • Clearance (CL): A measure of how fast the body removes a medicine.
  • Maximum plasma concentration (Cmax): The highest level of the medicine found in the blood.
  • Minimum plasma concentration (Cmin): The lowest level of the medicine found in the blood before the next dose.
  • Area under the curve (AUC): A measure of the total amount of medicine in the blood over time.
  • Half-life (t1/2): The time it takes for the amount of medicine in the body to fall by half.
  • Adverse event (AE): Any unwanted health problem that happens during a study.
  • Serious adverse event (SAE): A severe unwanted health problem that may need hospital care or may be life-threatening.
  • Bloodstream infection: An infection that has spread into the blood.
  • Ventilator-associated pneumonia: Lung infection that happens in a person who is using a breathing machine.

References