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) -

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infectious Diseases
• Intervention / Treatment: Drug: Avibactam sodium/Ceftazidime hydrate

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta for the first time

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Avibactam sodium/Ceftazidime hydrate; Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta (Avibactam sodium/Ceftazidime hydrate) for the first time	Drug: Avibactam sodium/Ceftazidime hydrate; The recommended adult dosage is 2.5 g (0.5 g of avibactam and 2 g of ceftazidime) administered by intravenous infusion over a period of 2 hours 3 times daily. For peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess, Zavicefta should be co-administered with a metronidazole injection.; Other Names: Zavicefta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with adverse drug reactions (ADRs)	From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Clinical Effectiveness	From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
Number of Participants with Clinical Effectiveness at the time of Test of Cure	28 days after the start of the administration

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Communicable Diseases; Renal Insufficiency; Third Generation Cephalosporins; Beta Lactam Antibiotics; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; beta-Lactamase Inhibitors; Avibactam; Ceftazidime
• Other Study ID Numbers: C3591038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.