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

Pfizer

Status: Begins enrollment in 1 month

Conditions: Infectious Diseases

Treatments: Drug: Avibactam sodium/Ceftazidime hydrate

Study type: Observational

Funder types: Industry

Identifiers

NCT06864585

C3591038

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: All

Volunteers: No 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

Exclusion criteria

There are no exclusion criteria for this study.

Trial design

59 participants in 1 patient group

Avibactam sodium/Ceftazidime hydrate

Description:

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

Treatment:

Drug: Avibactam sodium/Ceftazidime hydrate