A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea

NCT05733104 | Recruiting

• 1 other identifier: C3591027
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen, urinary tract and pneumonia which could have come from hospitalizations. This study was required by the Ministry of Food and Drug Safety (MFDS) of Korea's regulations.

Conditions

Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection; Hospital-acquired Pneumonia

Keywords

Ceftazidime; Avibactam; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Number of patient reporting an adverse event

  Safety will be assessed based on adverse events reported for all patients who received at least one dose of Zavicefta and completed safety follow-up.

  From first dose to end of the observation period (at least 28 calendar days following the last dose)

Secondary Outcomes (1)

• Clinical response: Number of patient recorded as cure

  up to one year

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 600 subjects who are eligible for Zavicefta IV accoding to its product label will be enrolled by continuous registration method and will be researched under routine clinical setting of Korea.

1. Adults and paediatric patients aged 3 months and older, who have been administered at least one dose of Zavicefta for the treatment of one of the indications as follows: * Complicated intra-abdominal infection (cIAI) * Complicated urinary tract infection (cUTI), including pyelonephritis * Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) * Other aerobic Gram-negative organism infection with limited treatment options 2. Adults 19 years of age or older, who have been administered at least one dose of Zavicefta for the treatment of the indication as follows: •Bacteremia associated with or suspected to be associated with cIAI, cUTI or HAP including VAP. 3. Patients are treated with Zavicefta for the first time 4. Patients have signed the data privacy statement.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, Gangnam-gu, 06273, South Korea

RECRUITING

Related Links

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

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 17, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): September 28, 2029
• Study Completion (Estimated): September 28, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)