A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea

Pfizer

Status: Enrolling

Conditions: Hospital-acquired Pneumonia; Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT05733104

C3591027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. 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

2. 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.

3. Patients are treated with Zavicefta for the first time

4. Patients have signed the data privacy statement.