Real-World Observational Study Of Zavicefta to Characterize Use Patterns
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 630
Summary
- Conditions
- Infection
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This observational study will include approximately 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam. Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patient...
This observational study will include approximately 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam. Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurs first. Data will be abstracted from medical records using an electronic case report form (eCRF). Baseline data include patient socio-demographics, medical history, and clinical and microbiological characteristics of the infection treated. Follow-up data will include details of treatment over time and clinical, microbiological, and healthcare resource utilization outcomes. Evaluation of clinical success will be performed in patients with at least ?72 hours of exposure to ceftazidime-avibactam. Safety will be evaluated in all patients exposed to at least one dose of the product.
Tracking Information
- NCT #
- NCT03923426
- Collaborators
- Not Provided
- Investigators
- Study Director: Pfizer CT.gov Call Center Pfizer