Clinical trial Recruiting at 1 site Observational Ages 3 Months and up

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.

More Urinary Tract Infection (Diagnosis) trials

Quick facts

Study typeObservational
Ages3 Months and up
SexAll
Enrollment600 (estimated)
SponsorPfizer
Industry-sponsored
Locations1 site (Seoul, Gangnam-gu)
StatusRecruiting
StartedFebruary 19, 2024
Main results expectedSeptember 28, 2029
Study endsSeptember 28, 2029
Registry record updatedSeptember 8, 2026
Trial IDNCT05733104 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.