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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying infections caused by gram-negative bacteria in newborns and infants under 9 months old. These infections can include complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired pneumonia, ventilator-associated pneumonia, sepsis, and bloodstream infections. The study will use a combination of medications called Aztreonam and Avibactam, with or without Metronidazole, to treat these infections. Aztreonam and Avibactam are antibiotics that work together to fight bacteria, while Metronidazole is another type of antibiotic that can be used to treat certain infections.

The purpose of this study is to learn more about how these medications work in the body, as well as to check their safety and how well they are tolerated by the infants. The study will be conducted in two parts, where the infants will receive either a single dose or multiple doses of the medications. The medications will be given through an intravenous infusion, which means they will be delivered directly into the bloodstream through a vein. The study will monitor the infants closely to see how their bodies process the medications and to watch for any side effects or reactions.

Throughout the study, researchers will collect information on how the medications affect the infants' infections and overall health. This includes checking the levels of the medications in the blood, observing any side effects, and assessing the infants' recovery from the infections. The study aims to provide valuable information that could help improve the treatment of serious bacterial infections in very young children.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be hospitalized and will receive treatment for suspected or confirmed bacterial infections. These infections may include complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia, ventilator-associated pneumonia, blood stream infection, or sepsis.

  2. Step 2

    Receiving medication

    The patient will receive medications through an intravenous infusion. The medications include metronidazole and a combination of aztreonam and avibactam sodium. Metronidazole is administered as a 500 mg/100 ml solution for infusion.

    Aztreonam and avibactam are provided as a powder for concentrate, which is then prepared as a solution for infusion. The dosage for aztreonam and avibactam is 1.5g/0.5g.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's response to the medication will be closely monitored. This includes measuring the levels of the medications in the blood on Day 1 and at a steady state, which is Day 2 or later.

    The patient's liver and kidney functions will be assessed at the beginning of the treatment, during the treatment, and after the treatment ends.

  4. Step 4

    Evaluating outcomes

    The trial will evaluate the effectiveness of the treatment by looking at clinical outcomes at the end of intravenous treatment, the end of treatment, and a test of cure.

    The response to the treatment will be assessed for each type of bacteria causing the infection and for the patient overall.

  5. Step 5

    Safety monitoring

    The trial will monitor for any adverse events, which are any unwanted effects of the medication. Serious adverse events will also be tracked, including any that lead to stopping the treatment or result in death.

Who can join the trial?

3 criteria

  • Must be hospitalized and aged from birth to less than 9 months, including those born early (preterm).
  • For Part A: Must be receiving intravenous (IV) antibiotics for a suspected or confirmed bacterial infection. This includes, but is not limited to, complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia, ventilator-associated pneumonia, blood stream infection, or sepsis.
  • For Part B: Must have a suspected or confirmed infection caused by gram-negative bacteria that requires IV antibiotics. This includes, but is not limited to, the same types of infections as in Part A.

Who cannot join the trial?

10 criteria

  • Patients with a known allergy or sensitivity to the study medication or its ingredients cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with a history of severe allergic reactions to any antibiotics are excluded.
  • Patients with a current or recent history of drug or alcohol abuse cannot join the study.
  • Patients with any other medical condition that the study doctors believe would make participation unsafe are not eligible.
  • Patients who are unable to comply with the study procedures or follow-up visits are excluded.
  • Patients with a history of liver disease or abnormal liver function tests are not eligible.
  • Patients with a history of kidney disease or abnormal kidney function tests are excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients with a history of seizures or epilepsy are not eligible.
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Investigated drugs

  • Aztreonam

    is an antibiotic used to treat infections caused by certain bacteria. In this trial, it is being studied for its effectiveness in treating serious infections in newborns and infants. These infections can include those in the urinary tract, abdomen, lungs, blood, or cases of sepsis. Aztreonam works by stopping the growth of bacteria, helping the body to overcome the infection.

  • Avibactam

    is a medication that is used in combination with other antibiotics to help them work better. It does not kill bacteria on its own but helps other antibiotics, like Aztreonam, to be more effective against bacteria that are resistant to treatment. In this trial, Avibactam is being tested to see how well it works with Aztreonam in treating serious infections in young patients.

  • Metronidazole

    is another type of antibiotic that is used to treat infections caused by bacteria and certain parasites. It is often used for infections in the abdomen and other areas of the body. In this trial, Metronidazole is being studied to see if it can help treat infections in newborns and infants when used alongside Aztreonam and Avibactam.

What is already known about the treatment

  • Aztreonam

    Aztreonam is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its effectiveness and safety in treating serious infections caused by gram-negative bacteria, especially in young infants. The main conditions it targets include complicated intra-abdominal infections, urinary tract infections, pneumonia acquired in hospitals, sepsis, and bloodstream infections. Aztreonam works by disrupting the bacteria's ability to build their cell walls, which ultimately leads to the bacteria's death. It is classified as a monobactam antibiotic, a type of medication specifically used to fight bacterial infections.

  • Avibactam

    Avibactam is also administered intravenously and is often used in combination with other antibiotics to enhance their effectiveness. It is being evaluated in clinical trials for its role in treating severe infections in infants caused by resistant gram-negative bacteria. Avibactam's primary function is to inhibit certain enzymes produced by bacteria that can break down antibiotics, thereby allowing the antibiotics to work more effectively. It is classified as a beta-lactamase inhibitor, which means it helps protect antibiotics from being destroyed by bacterial enzymes.

  • Metronidazole

    Metronidazole is administered intravenously and is used in combination with other antibiotics to treat infections caused by bacteria and certain parasites. In clinical trials, it is being studied for its potential benefits in treating complicated infections in infants. Metronidazole works by entering the bacterial cells and disrupting their DNA, which prevents the bacteria from multiplying and leads to their death. It is classified as an antiprotozoal and antibacterial agent, used to treat a variety of infections.

Investigated diseases

  • Complicated Intra-abdominal Infection

    This condition involves infections within the abdominal cavity that are severe and often involve multiple organs. It typically arises when bacteria enter the abdominal space due to a perforation or other injury. The infection can spread rapidly, leading to inflammation and abscess formation. Patients may experience severe abdominal pain, fever, and signs of systemic infection. The condition often requires prompt medical intervention to prevent further complications. It is a serious condition that can affect the function of the abdominal organs.

  • Suspected or Confirmed Infections Due to Gram-Negative Pathogens Requiring Intravenous Antibiotic Treatment

    These infections are caused by gram-negative bacteria, which are known for their resistance to many antibiotics. They can occur in various parts of the body, including the lungs, urinary tract, and bloodstream. The infections can progress quickly, leading to severe symptoms such as high fever, chills, and organ dysfunction. Intravenous antibiotics are often necessary to manage these infections effectively. The bacteria's resistance mechanisms can complicate treatment, requiring careful selection of antibiotics. These infections are particularly concerning in hospital settings.

  • Hospital-acquired pneumonia or ventilator-associated pneumonia

    This type of pneumonia occurs in patients during or after a stay in a hospital, particularly those on mechanical ventilation. It is caused by bacteria that are often resistant to standard antibiotics. The infection leads to inflammation of the lung tissue, resulting in symptoms such as cough, fever, and difficulty breathing. The condition can worsen rapidly, especially in patients with weakened immune systems. It is a common complication in intensive care units. The infection requires careful monitoring and management to prevent further lung damage.

  • Sepsis

    Sepsis is a severe and widespread response to infection that can affect the entire body. It occurs when the immune system releases chemicals into the bloodstream to fight an infection, causing widespread inflammation. This inflammation can lead to blood clots and leaky blood vessels, impairing blood flow and oxygen delivery to organs. Symptoms include fever, rapid heart rate, and confusion. If not managed promptly, it can lead to organ dysfunction. Sepsis requires immediate medical attention to control the infection and support organ function.

  • Complicated Urinary Tract Infection

    This type of urinary tract infection (UTI) is more severe and often involves the kidneys. It can occur when bacteria enter the urinary tract and multiply, leading to symptoms such as painful urination, frequent urge to urinate, and abdominal pain. The infection can spread to the kidneys, causing back pain and fever. Complicated UTIs are often associated with underlying conditions that affect the urinary tract. They require more intensive treatment than simple UTIs. The condition can lead to further complications if not addressed promptly.

  • Blood Stream Infection

    Also known as bacteremia, this condition occurs when bacteria enter the bloodstream, leading to systemic infection. It can arise from infections in other parts of the body, such as the lungs or urinary tract. The presence of bacteria in the blood can trigger a strong immune response, causing symptoms like fever, chills, and low blood pressure. Bloodstream infections can spread to other organs, leading to further complications. They require prompt medical intervention to identify and treat the source of infection. The condition is particularly concerning in hospitalized patients.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-507757-15-01Protocol codeC3601010Estimated enrolment57 patientsSponsorPfizer Inc.

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