A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney F… (NCT06864585) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
59 participantsStarted 2026-09-15
Plain-language summary
The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.
Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.
This study is seeking for patients with:
* sepsis (A very serious infection in your blood caused by germ (a bacteria)) or
* renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.
Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.
Who can participate
Age range
0 Years
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.
Inclusion criteria
. Patients who received Zavicefta for the first time after the launch of Zavicefta
. Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
. Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
. Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use
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 Participants with adverse drug reactions (ADRs)
Timeframe: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)