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Clinical Trials in South Korea / NCT05733104
Recruiting Observational

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

NCT05733104 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pfizer
Phase
Observational
Started
2024-02-19
Last updated
2026-09-08

Condition(s) studied

Complicated Intra-abdominal InfectionComplicated Urinary Tract InfectionHospital-acquired Pneumonia

Study 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

Sex
ALL
Min age
3 Months
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of patient reporting an adverse event — 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.

Trial sites (1)

FacilityCityRegionStatus
Pfizer Seoul Gangnam-gu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05733104 on ClinicalTrials.gov ↗ ← All trials in South Korea