NCT06864585

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) -

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 59 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infectious Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2029-03-30
• Completion: 2029-03-30
• First posted: 2025-03-07
• Last updated: 2025-10-14