Learning about the safety and effectiveness of Zavicefta in Korea
Official title: Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
Run by Pfizer · NCT05733104 · Data updated 2026-11-12
This study is trying to learn how safe and effective Zavicefta is for treating serious infections in both adults and kids in Korea after it has been released for use.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Months and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul, Gangnam-gu) |
| Status | Recruiting |
| Started | February 19, 2024 |
| Main results expected | September 28, 2029 |
| Study ends | September 28, 2029 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT05733104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults and pediatric patients aged 3 months and older who have received at least one dose of Zavicefta for specific complicated infections.
✕Probably not a fit
Patients who have not been treated with Zavicefta or those with infections not covered by the study criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather data on the safety and effectiveness of Zavicefta after its market release in Korea. It focuses on patients with complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired pneumonia. The study will monitor adverse events and drug reactions in real-world clinical settings, as mandated by the Ministry of Food and Drug Safety (MFDS) of Korea. Participants will include both adults and pediatric patients who have received Zavicefta for their infections.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world safety and effectiveness of Zavicefta, potentially improving treatment outcomes for patients with difficult infections.
How similar studies have gone: Other studies have successfully monitored the safety and effectiveness of new medications post-marketing, making this approach both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Pfizer
Seoul, Gangnam-gu, South Korea Recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.