A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea (NCT05733104) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
South Korea600 participantsStarted 2024-02-19
Plain-language 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.
Who can participate
Age range
3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patient reporting an adverse event
Timeframe: From first dose to end of the observation period (at least 28 calendar days following the last dose)