Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia

This study is investigating a new antibiotic called Zerbaxa (ceftolozane/tazobactam) in children who have developed a lung infection (pneumonia) while staying in hospital. This type of infection is sometimes called 'nosocomial pneumonia'. The main goal is to understand if this new medicine is safe for children, how easily they tolerate it, and what side effects might occur. Researchers will also be looking at how the medicine moves through the body, how quickly it's used up, and how it's removed. This is a "Phase 1" study, which means it's one of the first steps in testing a new medicine in people, focusing on safety and basic understanding of how it works in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

03 Apr 2023

Nosocomial infection Pneumonia

What is this study about?

This study is focused on a new antibiotic called Zerbaxa. We are specifically looking at how this medicine works for children who have developed a lung infection, also known as pneumonia, while they are already in the hospital. These types of infections are sometimes called 'nosocomial infections' because they are picked up in a healthcare setting.

The main purpose of this study is to find out if Zerbaxa is safe for children, how well their bodies handle it, and what kinds of side effects, if any, they might experience. This information is really important because it helps doctors understand if a new medicine is suitable for use in younger patients. We'll be carefully monitoring participants for any unexpected reactions to the medicine.

Beyond safety, the study will also investigate how the children's bodies process the antibiotic. This involves understanding how much of the medicine gets into the bloodstream, how long it stays there, and how it eventually leaves the body. This information helps doctors work out the best dose and how often to give the medicine for future treatments. Learning about new, effective ways to treat serious infections in children is very important.

Key takeaways

The study is testing a new antibiotic called Zerbaxa for children.
It focuses on children with lung infections caught in hospital.
The main goals are to check safety, how well it's tolerated, and how the body uses the medicine.
It's a Phase 1 study, meaning it's an early stage of testing.
All ages and genders of children with this specific infection can potentially participate.

Who may be eligible?

To be considered for this study, patients must be children who have developed a lung infection (pneumonia) while they are in hospital. This type of infection is specifically what the study is looking to treat.

There are no specific age restrictions mentioned beyond being a child, nor are there any limitations based on whether a person is male or female. This means the study is open to children of all ages and genders who meet the criteria of having a hospital-acquired lung infection.

However, potential participants would need to be thoroughly assessed by the study doctors to make sure they meet all the detailed health requirements, and that taking part is suitable and safe for them.

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 the person a child?
Does the child have pneumonia (a lung infection)?
Did the child get this lung infection while in hospital?
Is the child currently in hospital?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving the study medication, Zerbaxa, as an infusion (given through a drip). You would be closely monitored by doctors and nurses to check for any side effects and see how you are responding to the treatment. There would be regular checks of your health, likely including blood tests, to measure the levels of the medicine in your body and to keep an eye on your overall health. The exact number of hospital visits or the total length of time you'd be involved isn't specified in detail here, but it would involve regular assessments during active treatment and potentially some follow-up appointments.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and helping advance medical knowledge. However, there are also potential risks, including side effects from the new medication or inconvenience from study procedures like frequent blood tests. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Greece
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Unverified
Spain
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Unverified
Estonia

Common questions

What is Zerbaxa?

Zerbaxa is an antibiotic medication being studied to treat certain infections. In this study, it's being tested for lung infections children get in hospital.

What does a 'Phase 1' study mean?

Phase 1 is the first stage of testing a new medicine in people. The main goal is to check how safe it is, how well people tolerate it, and how the body handles the medicine.

Will I get better if I join this study?

While the aim is to find effective treatments, there's no guarantee that participating in a study will improve your health. Doctors will monitor your progress closely.

What are 'side effects'?

Side effects are any unwanted or unexpected reactions to a medicine. Researchers will carefully track these to understand Zerbaxa's safety.

Can I stop participating in the study at any time?

Yes, you or your child can stop being part of the study at any point, for any reason, and it will not affect your future medical care.