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Clinical Trial Summary

The aim of this study is to describe the use of cefiderocol in the management of Gram-negative infections (GNIs) in participants treated through the Early Access Program (EAP) in Spain.


Clinical Trial Description

This is a multicenter, retrospective, chart review of existing medical records in participants who received cefiderocol for a GNI as part of the Shionogi EAP. Access to cefiderocol was granted as Medication not approved in Spain subject to RD 1015/2009, which dictates that each case is approved on an individual basis by the Spanish Agency of Medicines. This study will be conducted at Spanish sites where cefiderocol was supplied via the EAP, beginning in 2018. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05789199
Study type Observational
Source Shionogi Inc.
Contact
Status Completed
Phase
Start date July 31, 2022
Completion date June 16, 2023

See also
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