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.
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
None
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.
Case-only
Prospective
Not listed
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.
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
