A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia. Basic parameters: from 3 months · 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
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
Overview
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.
Detailed description
The objective of this study is to determine any problems or questions associated with Zavicefta after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".
1. Serious adverse event/adverse drug reaction 2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label. 3. Known adverse drug reaction 4. Non-serious adverse drug reaction 5. Other safety and effectiveness information As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. This reserach shall begin after approval of marketing in Korea by MFDS.
Primary outcome measures
- Number of patient reporting an adverse event [Time frame: From first dose to end of the observation period (at least 28 calendar days following the last dose)]
Secondary outcome measures (1)
- Clinical response: Number of patient recorded as cure [Time frame: up to one year]
Eligibility criteria
- 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
- 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.
- Patients are treated with Zavicefta for the first time
- Patients have signed the data privacy statement.
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
- Case-only
Study locations
South Korea · 1 center
- Pfizer — Seoul
Identifiers
NCT: NCT05733104 · C3591027