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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05733104
Recruitment Status : Not yet recruiting
First Posted : February 17, 2023
Last Update Posted : June 5, 2023
Information provided by (Responsible Party):

Brief 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.

Condition or disease
Complicated Intra-abdominal Infection Complicated Urinary Tract Infection Hospital-acquired Pneumonia

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : January 1, 2029
Estimated Study Completion Date : September 28, 2029

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05733104

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Contact: Pfizer Call Center 1-800-718-1021

Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Pfizer Identifier: NCT05733104    
Other Study ID Numbers: C3591027
First Posted: February 17, 2023    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Intraabdominal Infections
Healthcare-Associated Pneumonia
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Cross Infection
Iatrogenic Disease