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

NCT ID: NCT05733104

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2029-09-28

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer

Seoul, Gangnam-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Pfizer CT.gov Call Center

Role: CONTACT

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3591027

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

Other Identifiers

C3591027

Identifier Type: -

Identifier Source: org_study_id