RecruitingNCT05733104

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

Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV


Sponsor

Pfizer

Enrollment

600 participants

Start Date

Feb 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 3 Months

Inclusion Criteria9

  • 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.

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Locations(1)

Pfizer

Seoul, Gangnam-gu, South Korea

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NCT05733104


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