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Avibactam sodium/Ceftazidime hydrate / Infectious Diseases · Observational Study
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active observational registry record for a real-world safety and effectiveness study of ceftazidime–avibactam (Zavicefta) in Japanese patients with sepsis or renal impairment. No outcomes have been reported in this registry entry; the study is ongoing and results are not yet posted.
Observational. Infectious Diseases; age from 0 Years. Intervention: Avibactam sodium/Ceftazidime hydrate. n = 59. 1 site: Japan.
This is an active observational registry record for a real-world safety and effectiveness study of ceftazidime–avibactam (Zavicefta) in Japanese patients with sepsis or renal impairment. No outcomes have been reported in this registry entry; the study is ongoing and results are not yet posted.
This is a registry record with no results posted; no outcome data, effect sizes, or safety signals are reported.
This observational study will provide real-world safety data on ceftazidime–avibactam use in a Japanese clinical practice setting, but clinicians should await final results before drawing conclusions. The observational design and lack of a control group limit causal inference.
This is an active observational registry record with no reported results; it describes a planned safety and effectiveness study in a specific population and geography with no outcome data yet posted.
As stated by the source record.
Quoted from the source exactly as published.
This observational study will provide real-world safety data on ceftazidime–avibactam use in a Japanese clinical practice setting, but clinicians should await final results before drawing conclusions. The observational design and lack of a control group limit causal inference.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06864585). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 59 participants (ACTUAL). Conditions: Infectious Diseases. Interventions: DRUG: Avibactam sodium/Ceftazidime hydrate. Primary outcome measures: Number of Participants with adverse drug reactions (ADRs) , 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). Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.