Treatment outcomes from Retrospective Analysis of patient Charts for AztrEonam/Avibactam (TRACE)  

14/08/2026
17/08/2026
EU PAS number:
EUPAS1000000956
Study
Finalised

ENCePP Code of conduct

N/A
Data sources

Data source(s), other

The data source for this study will be patient medical records and hospital laboratory information management systems for detailed microbiological results data. The data generated in participating sites will be collected by trained site personnel and entered into the research platform through electronic case report forms (eCRFs). Data will be abstracted from patient medical charts (either electronic or hard copies) after treatment completion and records of hospital readmissions will be identified up to 30 days post discharge for the index hospitalization. Censoring events will be tracked by Investigator sites during data abstraction activities. The clinical outcomes will be obtained from investigator assessments.

Data sources (types)

Non-interventional study
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No