Trials / Recruiting
RecruitingNCT05733104
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2024-02-19
- Primary completion
- 2029-09-28
- Completion
- 2029-09-28
- First posted
- 2023-02-17
- Last updated
- 2025-09-03
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05733104. Inclusion in this directory is not an endorsement.