Actively Recruiting
Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
Led by Pfizer · Updated on 2025-09-03
600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Zavicefta in patients with difficult infections in the abdomen, urinary tract, and pneumonia, including infections possibly acquired during hospital stays. This observational study follows regulations by the Ministry of Food and Drug Safety (MFDS) in Korea and focuses on real-world use after Zavicefta is released in the Korean market. The study aims to collect data on adverse events and treatment responses during routine clinical practice. The study involves patients who have been given at least one dose of Zavicefta for approved infections such as complicated intra-abdominal infection, complicated urinary tract infection including pyelonephritis, hospital-acquired pneumonia including ventilator-associated pneumonia, and other infections caused by aerobic Gram-negative bacteria with limited treatment options. Patients receiving Zavicefta for the first time are included. The study period covers monitoring from the first dose and continues for at least 28 days post-treatment, with follow-up up to one year for clinical response assessment. Participants will be observed during their usual medical care while data is collected on any adverse events or drug reactions, including both expected and unexpected effects. Researchers will track the number of patients reporting adverse events and evaluate treatment outcomes such as clinical cure rates. This post-marketing surveillance study continues for six years after Zavicefta's approval to ensure ongoing safety and effectiveness monitoring in real-world settings.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 months and older who have received at least one dose of Zavicefta for treatment of complicated intra-abdominal infection, complicated urinary tract infection including pyelonephritis, hospital-acquired pneumonia including ventilator-associated pneumonia, or other aerobic Gram-negative infections with limited treatment options
- Adults 19 years or older who have received at least one dose of Zavicefta for bacteremia associated with or suspected to be associated with the above infections
- Patients treated with Zavicefta for the first time
- Patients who have signed the data privacy statement
You will not qualify if you...
- Patients who have not been treated with Zavicefta
- Patients younger than 3 months old
- Patients who have not signed the data privacy statement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 28 calendar days following the last dose
Participants who undergo routine care with Zavicefta are observed for safety and effectiveness in general clinical practice.
Visits as per routine clinical practice
Duration - Up to 1 year
Participants are followed for up to one year to record clinical response and safety outcomes.
Visits as per routine clinical practice
Trial Site Locations
Total: 1 location
1
Pfizer
Seoul, Gangnam-gu, South Korea, 06273
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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