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

Hospital-acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733104
• Other study ID #: C3591027
• Status: Recruiting
• Start date: February 19, 2024
• Est. completion date: September 28, 2029

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 28, 2029
• Est. primary completion date: September 28, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-abdominal Infection
• Complicated Urinary Tract Infection
• Healthcare-Associated Pneumonia
• Hospital-acquired Pneumonia
• Infections
• Intraabdominal Infections
• Urinary Tract Infections

Locations

Country	Name	City	State
Korea, Republic of	Pfizer	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient reporting an adverse event	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.	From first dose to end of the observation period (at least 28 calendar days following the last dose)
Secondary	Clinical response: Number of patient recorded as cure	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	up to one year

External Links

•   To obtain contact information for a study center near you, click here.