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

Recruiting

• Conditions: Hospital-acquired Pneumonia; Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection

• Registration Number: NCT05733104
• Lead Sponsor: Pfizer

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.

Detailed Description

The objective of this study is to determine any problems or questions associated with Zavicefta after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".

1. Serious adverse event/adverse drug reaction

2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.

3. Known adverse drug reaction

4. Non-serious adverse drug reaction

5. Other safety and effectiveness information As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. This reserach shall begin after approval of marketing in Korea by MFDS.

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Study Start: 2024-02-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2029-09-28
• Study Completion: 2029-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patient reporting an adverse event	From first dose to end of the observation period (at least 28 calendar days following the last dose)	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.

Secondary Outcome Measures

Name	Time	Method
Clinical response: Number of patient recorded as cure	up to one year	Clinical response will be evaluated as follows based on subjective assessment by the investigator after the patient has been subjected to the conditions corresponding to each clinical response item or after interviewing the patient at the end of treatment: Cure: Complete resolution or significant improvement of signs and symptoms of the index infection, such that no further antibacterial therapy was necessary; Failure: Death related to the index infection or received treatment with additional antibiotics for ongoing symptoms of index infection; Indeterminate: study data were not available for evaluation of effectiveness for any reason

Trial Locations

Locations (1)

Pfizer; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of