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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3 months
Healthy Volunteers: f
View:

‣ 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.

Locations
Other Locations
Republic of Korea
Pfizer
RECRUITING
Seoul
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2029-09-28
Participants
Target number of participants: 600
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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