AuthorisedTherapeutic exploratory (Phase II)Interventional

C3601010: A Phase 2A, 2-Part, Open-Label, Non-Randomized, Multicenter, Single and Multiple Dose Trial to Evaluate Pharmacokinetics, Safety and Tolerability of Aztreonam and Avibactam ± Metronidazole in Neonates and Infants From Birth to Less Than 9 Months of Age With Suspected or Confirmed Infections Due to Gram-Negative Pathogens Requiring Intravenous Antibiotic Treatment

This study is looking at a new combination antibiotic medicine called Aztreonam and Avibactam, sometimes given with another medicine called Metronidazole. It's for very young babies, from birth up to 9 months old, who have serious bacterial infections that need strong medicines given directly into their veins. These infections might include conditions like sepsis (a severe reaction to an infection), kidney infections, or blood infections. The main goal is to understand how these new antibiotics behave in a baby's body – for example, how much medicine is needed and how long it stays in their system. The study also carefully checks for any side effects to make sure the medicines are safe and well-tolerated by these vulnerable patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

30 Apr 2025

Sepsis Suspected or Confirmed Infections Due to Gram-Negative Pathogens Requiring Intravenous Antibiotic Treatment Complicated Urinary Tract Infection Blood Stream Infection Hospital-acquired pneumonia or ventilator-associated pneumonia Complicated Intra-abdominal Infection

What is this study about?

This study is investigating a new way to treat serious bacterial infections in very young children, specifically babies from birth up to 9 months of age. These infections, often caused by 'Gram-negative' bacteria, can be very dangerous and include conditions like sepsis (a life-threatening response to an infection), severe kidney or bladder infections, blood infections, and lung infections that can happen in hospitals, including those in babies needing breathing support.

The treatment being tested is a combination of two antibiotic medicines, Aztreonam and Avibactam. Sometimes, another antibiotic called Metronidazole might also be given alongside them. These medicines are given directly into the baby's vein. The main purpose of this study is to learn more about how these medicines work in a baby's body. Because babies are so small and their bodies are still developing, medicines can affect them differently than adults or older children. Researchers need to understand things like how much of the medicine gets into the blood, how long it stays there, and how the baby's body processes it.

Crucially, the study also focuses on safety. Doctors will be closely monitoring the babies for any side effects or unwanted reactions to the medicines. They will also check how well the baby's liver and kidneys are working before, during, and after treatment, as these organs are important for processing medicines. By gathering this information, researchers hope to find the safest and most effective way to treat these serious infections in very young patients, which is vital as there aren't always many good options for them.

Key takeaways

Targets serious bacterial infections in babies up to 9 months old.
Tests a new antibiotic combination (Aztreonam and Avibactam).
Aims to understand how medicines work and their safety in babies.
Babies will receive medicines intravenously (through a drip).
Close monitoring is a key part of the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for babies from birth up to 9 months of age. Both boys and girls can take part. To be included, babies must have a suspected or confirmed serious infection caused by certain types of bacteria, called Gram-negative bacteria, that requires treatment with antibiotics given directly into their veins.

This means the study is looking for very young patients who are already quite unwell with specific kinds of infections. The medical team will check detailed criteria to make sure it's the right study for your baby, ensuring their safety and the study's scientific goals are met.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my baby between birth and 9 months old?
Does my baby have a suspected or confirmed serious bacterial infection?
Does this infection require antibiotics to be given through a drip (into a vein)?
Has my baby's doctor suggested this study might be suitable for them?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive the study medicines (Aztreonam and Avibactam, possibly with Metronidazole) through a drip into their vein. Doctors will regularly test your baby's blood to see how much of the medicine is in their system and how their body is handling it. This helps them understand how the treatment works in very young children. They will also carefully monitor your baby for any side effects, and check their liver and kidney health. There will be several hospital visits for these treatments and checks, both during the time your baby is receiving the medicine and for a short period afterwards to make sure they are recovering well and the infection is gone. The total duration of participation will depend on how long your baby needs treatment and follow-up, but generally involves checks during treatment and for a period after the last dose.

Potential risks and benefits

Taking part in a study like this means your baby might receive a new treatment that could potentially be more effective for their serious infection, especially if standard treatments aren't working well or don't exist. The study involves close monitoring, which means your baby will receive a high level of medical care and attention. However, like all medicines, the antibiotics being tested can have side effects, and we don't know everything about how they will affect very young babies. There is a risk of both known and unknown side effects. You will receive detailed information about these potential risks. You always have the right to withdraw your baby from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovakia
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Unverified
Greece
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Unverified
Bulgaria
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Unverified
Italy
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Unverified
Hungary
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Unverified
Spain

Common questions

What kind of infections is this study looking at?

It's for serious bacterial infections like sepsis, severe kidney or bladder infections, blood infections, and hospital-acquired lung infections in very young babies.

Are the medicines new?

It's a new combination of antibiotics, Aztreonam and Avibactam, sometimes with another existing antibiotic called Metronidazole.

Why focus on babies?

Babies' bodies handle medicines differently. This study helps find the safest and most effective way to treat these serious infections in very young patients.

Will my baby be closely watched?

Yes, your baby will be very closely monitored for how the medicine works, side effects, and organ health (like liver and kidneys).

Can I take my baby out of the study if I change my mind?

Yes, you can choose to withdraw your baby at any time, and their medical care will not be affected.