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.
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 Type
OBSERVATIONAL
Enrollment
314
Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.
Rate Of Clinical Success
The rate of clinical success will be reported as the percent clinical success of participants treated with cefiderocol for participants who receive at least 72 hours of cefiderocol through the EAP for the treatment of Gram-negative, carbapenem-resistant infections (except for Acinetobacter spp).
Time frame: From Day 1 (cefiderocol initiation) through Day 28
Number of Participants Experiencing Resolution of Infection or Clinical Cure After Treatment With Cefiderocol
Time frame: Day 1 (cefiderocol initiation), every 7 days up to Day 28
In-hospital Length of Stay
Length of stay in hospital (days) for participants with infections treated by cefiderocol will be reported.
Time frame: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Length of Stay in Intensive Care Unit (ICU)
Length of stay in ICU (days) for participants with infections treated by cefiderocol will be reported.
Time frame: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Length of Invasive Ventilation
Length of invasive ventilation (days) for participants with infections treated by cefiderocol will be reported.
Time frame: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
All-cause In-hospital Mortality
All-cause in-hospital mortality will be reported after cefiderocol initiation.
Time frame: Day 14, Day 28
Cause of Death
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Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital General Universitario de Alicante Doctor Balmis
Alicante, Spain
Hospital Universitario de Torrevieja
Alicante, Spain
Hospital Universitario San Juan de Alicante
Alicante, Spain
Hospital Vega Baja de Orihuela
Alicante, Spain
Hospital Universitario Torrecardenas, Almeria
Almería, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
...and 45 more locations
The relation of death to the reference infection, as reported in the medical notes, will be reported.
Time frame: Day 1 (cefiderocol initiation) through Day 28
Rate of Microbiological Eradication
The rate of eradication of carbapenem-resistant GNIs will be reported as the percent microbiological eradication among participants with blood stream infections (BSIs) and complicated urinary tract infections (cUTIs)/UTIs from 24 hours of cefiderocol initiation until Day 28. BSI microbiological eradication will be defined as the absence of a positive follow-up blood culture, in which the same organism as the initial blood culture was obtained. Any positive blood cultures drawn within 24 hours of the initial positive culture will be considered as the same episode. cUTI/UTI microbiological eradication will be defined as an absence of a positive follow-up culture of the same organism as the initial infection obtained.
Time frame: Day 1 (24 hours post cefiderocol initiation) through Day 28
Severity of Illness
The severity of illness at the time of cefiderocol administration at baseline will be described by a Sequential Organ Failure Assessment (SOFA) Score, quickSOFA (qSOFA) score, level of organ support, and presence of septic shock. The SOFA score for participants in ICU or qSOFA score for participants outside ICU will be reported for days -3, 0, and 7 in relation to the date of cefiderocol initiation.
Time frame: Day 1 (cefiderocol initiation) through Day 28
Number of Participants With Adverse Drug Reactions (ADRs)
The number of participants with serious and non-serious adverse events with explicit attribution to cefiderocol (ADR) will be reported.
Time frame: Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first)
Number of Participants Experiencing Resolution of Infection or Clinical Cure After Prolonged Treatment With Cefiderocol
Time frame: Day 1 (cefiderocol initiation), every 10 days up to Day 60