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Search / Trial NCT06864585

A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan

Launched by PFIZER · Mar 3, 2025

Trial Information

Current as of April 25, 2025

Not yet recruiting

Keywords

Sepsis; Renal Impairment; Zavicefta; Avibactam; Ceftazidime

ClinConnect Summary

This clinical trial is studying a medication called Zavicefta, which is used to treat serious infections in the blood (known as sepsis) and patients with reduced kidney function. The main goal of the study is to understand how safe and effective Zavicefta is when used in everyday medical practice in Japan. This trial will involve patients who are receiving Zavicefta for the first time and have either sepsis or kidney issues.

To be eligible for the study, participants must be diagnosed with sepsis or have a specific measure of kidney function that is below normal when they start treatment. There are no specific exclusions, meaning most patients who meet the criteria can participate. If you join the study, you will be monitored from the day you start taking Zavicefta until 28 days later. This trial aims to gather important information that can help improve treatment for patients with these serious conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients who received Zavicefta for the first time after the launch of Zavicefta
  • 2. Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
  • 3. Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
  • 4. Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use
  • Exclusion Criteria:
  • There are no exclusion criteria for this study.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

Patients applied

0 patients applied

Trial Officials

Pfizer CT.gov Call Center

Study Director

Pfizer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported