A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avibactam sodium/Ceftazidime hydrate.
- Who it may be relevant to
- Registry conditions: Infectious Diseases. Basic parameters: from 0 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -
Overview
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.
Interventions
- Drug Avibactam sodium/Ceftazidime hydrate
The recommended adult dosage is 2.5 g (0.5 g of avibactam and 2 g of ceftazidime) administered by intravenous infusion over a period of 2 hours 3 times daily. For peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess, Zavicefta should be co-administered with a metronidazole injection.
Primary outcome measures
- Number of Participants with adverse drug reactions (ADRs) [Time frame: 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)]
Secondary outcome measures (2)
- Number of Participants with Clinical Effectiveness [Time frame: 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)]
- Number of Participants with Clinical Effectiveness at the time of Test of Cure [Time frame: 28 days after the start of the administration]
Eligibility criteria
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
Exclusion criteria
There are no exclusion criteria for this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06864585 · C3591038