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

Not yet recruiting

• Conditions: Infectious Diseases
• Interventions: Drug: Avibactam sodium/Ceftazidime hydrate

• Registration Number: NCT06864585
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Study Start: 2025-09-15
• Primary Completion: 2029-03-30
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Avibactam sodium/Ceftazidime hydrate	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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