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

NCT06864585 | Not Yet Recruiting

• 1 other identifier: C3591038
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infectious Diseases

Keywords

Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Avibactam sodium/Ceftazidime hydrate

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

Drug: Avibactam sodium/Ceftazidime hydrate

Interventions

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.

Also known as: Zavicefta

Avibactam sodium/Ceftazidime hydrate

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Communicable Diseases; Sepsis; Renal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share