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NCT Number: NCT05733104

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

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.

Recruiting

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Key information

About this study

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".

  • Serious adverse event/adverse drug reaction
  • Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
  • Known adverse drug reaction
  • Non-serious adverse drug reaction
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. Number of patient reporting an adverse event

    Time frame: 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.

Secondary outcomes

  1. Clinical response: Number of patient recorded as cure

    Time frame: up to one year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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