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Completed

NCT Number: NCT05789199

Use of Cefiderocol in the Management of Gram-Negative Infections

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.

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Key information

Conditions

Gram-negative Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefiderocol

Drug

Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.

Primary outcomes

  1. Rate Of Clinical Success

    Time frame: 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 outcomes

  1. 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

  2. In-hospital Length of Stay

    Time frame: 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.

  3. Length of Stay in Intensive Care Unit (ICU)

    Time frame: 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.

  4. Length of Invasive Ventilation

    Time frame: 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.

  5. All-cause In-hospital Mortality

    Time frame: Day 14, Day 28

    All-cause in-hospital mortality will be reported after cefiderocol initiation.

  6. Cause of Death

    Time frame: Day 1 (cefiderocol initiation) through Day 28

    The relation of death to the reference infection, as reported in the medical notes, will be reported.

  7. Rate of Microbiological Eradication

    Time frame: 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.

  8. Severity of Illness

    Time frame: 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.

  9. Number of Participants With Adverse Drug Reactions (ADRs)

    Time frame: 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.

  10. 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

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program (PERSEUS Study)

Acronym: PERSEUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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