Learning about the safety and effectiveness of Zavicefta in Korea
Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 3 Months and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul, Gangnam-gu) |
| Trial ID | NCT05733104 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have successfully monitored the safety and effectiveness of new medications post-marketing, making this approach both relevant and necessary.
Eligibility criteria
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 this trial is running
Seoul, Gangnam-gu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.