Gram-Negative Infection
Conditions
Keywords
Cefiderocol, Early Access Program, Spain
Brief 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.
Detailed 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.
Interventions
DRUGCefiderocol
Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.
Sponsors
Shionogi
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Have received first course of cefiderocol. * Have received treatment for at least 72 hours (complete) with cefiderocol as a part of clinical compassionate management, requested in the EAP.
Exclusion criteria
* Enrolled in any clinical trial of an investigational product. * Documented Acinetobacter spp infection. * Incomplete medical records for the following essential data elements: * Cefiderocol usage (dose, duration, frequency) * Data to be able to determine clinical success (primary objective) * Co-infection with a GNB resistant to cefiderocol in 28 days of the initial dose of cefiderocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate Of Clinical Success | From Day 1 (cefiderocol initiation) through Day 28 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Length of Stay | Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first) | Length of stay in hospital (days) for participants with infections treated by cefiderocol will be reported. |
| Length of Stay in Intensive Care Unit (ICU) | Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first) | Length of stay in ICU (days) for participants with infections treated by cefiderocol will be reported. |
| Length of Invasive Ventilation | Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first) | Length of invasive ventilation (days) for participants with infections treated by cefiderocol will be reported. |
| All-cause In-hospital Mortality | Day 14, Day 28 | All-cause in-hospital mortality will be reported after cefiderocol initiation. |
| Number of Participants Experiencing Resolution of Infection or Clinical Cure After Treatment With Cefiderocol | Day 1 (cefiderocol initiation), every 7 days up to Day 28 | — |
| Rate of Microbiological Eradication | Day 1 (24 hours post cefiderocol initiation) through Day 28 | 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. |
| Severity of Illness | Day 1 (cefiderocol initiation) through Day 28 | 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. |
| Number of Participants With Adverse Drug Reactions (ADRs) | Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first) | The number of participants with serious and non-serious adverse events with explicit attribution to cefiderocol (ADR) will be reported. |
| Number of Participants Experiencing Resolution of Infection or Clinical Cure After Prolonged Treatment With Cefiderocol | Day 1 (cefiderocol initiation), every 10 days up to Day 60 | — |
| Cause of Death | Day 1 (cefiderocol initiation) through Day 28 | The relation of death to the reference infection, as reported in the medical notes, will be reported. |
Countries
Spain
Outcome results
None listed