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A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

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

Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -

NCT06864585•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan. Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate. This study is seeking for patients with: * sepsis (A very serious infection in your blood caused by germ (a bacteria)) or * renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time. Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

March 15, 2026

Primary Completion Date

March 30, 2029

Completion Date

March 30, 2029

Last Updated

October 14, 2025

Enrollment

ESTIMATED participants

Conditions

Infectious Diseases

Interventions

Avibactam sodium/Ceftazidime hydrate

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

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