Pfizer
Seoul, Gangnam-gu, 06273, South Korea
Location status: Recruiting
NCT Number: NCT05733104
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.
Interested in participating?
Request Info3 month and older
All sexes
Observational
Seoul, Gangnam-gu, 06273, South Korea
Location status: Recruiting
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".
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
•Bacteremia associated with or suspected to be associated with cIAI, cUTI or HAP including VAP.
Time frame: From first dose to end of the observation period (at least 28 calendar days following the last dose)
Safety will be assessed based on adverse events reported for all patients who received at least one dose of Zavicefta and completed safety follow-up.
Time frame: up to one year
Clinical response will be evaluated as follows based on subjective assessment by the investigator after the patient has been subjected to the conditions corresponding to each clinical response item or after interviewing the patient at the end of treatment:
Cure: Complete resolution or significant improvement of signs and symptoms of the index infection, such that no further antibacterial therapy was necessary
Failure: Death related to the index infection or received treatment with additional antibiotics for ongoing symptoms of index infection
Indeterminate: study data were not available for evaluation of effectiveness for any reason
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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