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OpenTrials
Active, not recruiting

NCT Number: NCT06864585

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Japan

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received Zavicefta for the first time after the launch of Zavicefta
  • Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
  • Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
  • 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.

Treatment and study plan

Avibactam sodium/Ceftazidime hydrate

Drug

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.

Other names: Zavicefta

Primary outcomes

  1. Number of Participants with adverse drug reactions (ADRs)

    Time frame: 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 outcomes

  1. Number of Participants with Clinical Effectiveness

    Time frame: 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)

  2. Number of Participants with Clinical Effectiveness at the time of Test of Cure

    Time frame: 28 days after the start of the administration

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 7, 2025
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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