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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Tartu University Hospital Tartu Estonia
Tallinn Children’s Hospital Foundation Mustamae Linnaosa Estonia
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Estonia Estonia
Not recruiting
26.05.2020
Greece Greece
Not recruiting
26.05.2020
Spain Spain
Not recruiting
26.05.2020

Trial locations

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.

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 ID:
2022-501110-56-00
Protocol code:
MK-7625A-036
NCT ID:
NCT04223752
Trial Phase:
Human Pharmacology (Phase I) – Other

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