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

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06864585

Enrollment

Registered

2025-03-07

Start date

2026-04-20

Completion date

2029-03-30

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Diseases

Keywords

Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime

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.

Interventions

DRUGAvibactam 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

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

Design outcomes

Primary

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

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

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026