An observational study in Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection and Hospital-acquired Pneumonia, sponsored by Pfizer. Recruiting at 1 site in South Korea. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Pfizer · Observational
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.
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".
121 studies on the registry are indexed under Healthcare-Associated Pneumonia; 22 are open to participants now.
This study's planned enrollment of 600 is above the median of 310 across 39 observational studies indexed under Healthcare-Associated Pneumonia.
Browse Healthcare-Associated Pneumonia studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
At least 600 subjects who are eligible for Zavicefta IV accoding to its product label will be enrolled by continuous registration method and will be researched under routine clinical setting of Korea.
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:
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.
Number of patient reporting an adverse event
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: From first dose to end of the observation period (at least 28 calendar days following the last dose)
Clinical response: Number of patient recorded as cure
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
Time frame: up to one year
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Healthcare-Associated Pneumonia →