Use of Cefiderocol in the Management of Gram-Negative Infections
- Registration Number
- NCT05789199
- Lead Sponsor
- Shionogi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cefiderocol Treated Cefiderocol Participants who have been treated with at least 72 hours of cefiderocol through the EAP in Spain.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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 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.
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 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.
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.
All-cause In-hospital Mortality Day 14, Day 28 All-cause in-hospital mortality will be reported after cefiderocol initiation.
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.
Trial Locations
- Locations (55)
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
🇪🇸Almeria, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Scroll for more (45 remaining)Complejo Hospitalario Universitario A Coruña🇪🇸A Coruña, Spain