Ireland
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Active, not recruiting Observational

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

NCT06864585 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Observational
Started
2026-04-20
Last updated
2026-08-17

Condition(s) studied

Infectious Diseases

Investigational drug(s) / intervention(s)

Avibactam sodium/Ceftazidime hydrate →

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.

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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)

Trial sites (1)

FacilityCityRegionStatus
Pfizer Japan Tokyo Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864585 on ClinicalTrials.gov ↗ ← All trials in Japan