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Study on the Safety of Ceftolozane and Tazobactam for Children with Hospital-Acquired Pneumonia

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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 nosocomial pneumonia, a type of lung infection that patients can acquire while staying in a hospital. The treatment being tested in this study is a combination of two substances, ceftolozane and tazobactam, which are administered together as a medication known by the code name MK-7625A. This medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and tolerability of this treatment in children who have been diagnosed with nosocomial pneumonia. Participants in the study will receive the medication and be monitored for any side effects or reactions. The study will also measure how the body processes the medication, including how it is absorbed, distributed, and eliminated. This information will help determine the appropriate dosage and frequency for treating this type of pneumonia in pediatric patients.

Throughout the study, researchers will collect data on the participants' health and any adverse events they may experience. This will help ensure that the treatment is safe and effective for children with nosocomial pneumonia. The study is designed to provide valuable insights into the use of ceftolozane and tazobactam in treating this serious infection in a hospital setting.

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 study

    Upon joining the study, you will be informed about the purpose and procedures of the clinical trial. This study aims to evaluate the safety and tolerability of a medication called ceftolozane/tazobactam in children with hospital-acquired pneumonia.

  2. Step 2

    Initial assessment

    You will undergo an initial assessment to confirm your eligibility. This includes ensuring you are hospitalized and expected to receive at least 8 days of standard antibiotic treatment for pneumonia.

    If you are male, you must agree to use contraception during the study and for 30 days after the last dose. If you are female, you must not be pregnant or breastfeeding, and if you are of childbearing potential, you must use acceptable contraception and have a negative pregnancy test before starting the study.

  3. Step 3

    Medication administration

    You will receive the study medication, Zerbaxa, which contains ceftolozane and tazobactam. This medication is given as an intravenous infusion, meaning it is administered directly into your vein.

    The dosage and frequency of the medication will be determined by the study team based on your specific needs and condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, you will be closely monitored for any adverse events or side effects. This includes regular blood tests to measure the levels of the medication in your body.

    The study team will also assess how your body processes the medication, including how long it stays in your system and how it is eliminated.

  5. Step 5

    Completion of the study

    Once you have completed the study, there will be a final assessment to evaluate your overall health and any effects of the medication.

    You will be informed about the results of the study and any important findings related to your participation.

Who can join the trial?

3 criteria

  • The patient must be hospitalized and expected to receive at least 8 days of standard antibiotic treatment for confirmed or suspected nosocomial pneumonia (a type of lung infection acquired in a hospital).
  • If the patient is male, he must either not engage in sexual intercourse with women or agree to use birth control during the study and for at least 30 days after the last dose of the study medication.
  • If the patient is female, she must not be pregnant or breastfeeding. If she is capable of becoming pregnant, she must use acceptable birth control, have a negative pregnancy test within 48 hours before the first dose of the study medication, or not engage in sexual intercourse with men.

Who cannot join the trial?

2 criteria

  • Patients with a **nosocomial infection** (an infection acquired in a hospital) cannot participate.
  • Patients with **pneumonia** (an infection that inflames the air sacs in one or both lungs) cannot participate.
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Investigated drugs

Ceftolozane/Tazobactam is a combination of two medications used to treat bacterial infections. Ceftolozane is an antibiotic that works by killing bacteria or stopping their growth. Tazobactam is a substance that helps ceftolozane work better by preventing bacteria from breaking it down. In this clinical trial, the combination is being tested to see if it is safe and well-tolerated in children with a type of lung infection called nosocomial pneumonia, which is an infection acquired in a hospital setting.

What is already known about the treatment

Ceftolozane/Tazobactam – This medication is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to assess its safety and how well it is tolerated in children with hospital-acquired pneumonia, a type of lung infection. The main use of this medication is to treat serious bacterial infections, particularly those acquired in a hospital setting. At the molecular level, ceftolozane works by disrupting the formation of the bacterial cell wall, leading to the death of the bacteria, while tazobactam helps prevent the bacteria from breaking down ceftolozane, making the treatment more effective. It is classified as an antibiotic, specifically a combination of a cephalosporin and a beta-lactamase inhibitor.

Investigated diseases

  • Nosocomial infection

    Nosocomial infections, also known as hospital-acquired infections, occur in patients during their stay in a healthcare facility. These infections are not present or incubating at the time of admission. They can be caused by bacteria, viruses, or fungi, often due to invasive procedures or weakened immune systems. The progression of nosocomial infections can vary depending on the pathogen and the patient's health. Symptoms may include fever, inflammation, and other site-specific signs. These infections can spread within the healthcare setting if not properly controlled.

  • Pneumonia

    Pneumonia is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus. It can be caused by bacteria, viruses, or fungi. The disease often begins with symptoms similar to a cold or flu, such as cough, fever, and difficulty breathing. As it progresses, symptoms can become more severe, including chest pain and a persistent cough with phlegm. Pneumonia can affect people of all ages but is more serious in infants, older adults, and those with weakened immune systems. The progression and severity depend on the cause and the individual's overall health.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2022-501110-56-00Protocol codeMK-7625A-036Estimated enrolment67 patientsSponsorMerck Sharp & Dohme LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).