NCT05544682

Brief Summary

Cefiderocol is a new antibiotic from the siderophore cephalosporin family for which there are few real-life data on its use in the treatment of infections with multidrug-resistant Gram-negative bacilli. The circulation of bacterial strains multi-resistant to antibiotics is important at the Strasbourg University Hospital, so the investigators wish to report their local experience of the 1st uses of Cefiderocol in the treatment of infections with multi-resistant Gram-negative bacilli to antibiotics in order to better clarify the use of this antibiotic (therapeutic indication, method of administration)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

September 13, 2022

Last Update Submit

December 12, 2023

Conditions

Keywords

Multidrug Resistant Bacterial InfectionsGram-negative bacilli infectionsCefiderocolAntibiotics

Outcome Measures

Primary Outcomes (1)

  • Retrospective evaluation of the therapeutic management of patients treated as part of routine care with Cefiderocol

    Survival, significant clinical improvement, absence of microbiological failure or infectious recurrence on day 30 after treatment with Céfiderocol

    30 days post treatment with Céfiderocol

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient (≥18 years old) taken care of in the HUS and treated as part of routine care with Cefiderocol between 04/01/2020 and 08/31/2022.

You may qualify if:

  • Adult patient (≥18 years old)
  • taken care of in the HUS and treated as part of routine care with Cefiderocol between 04/01/2020 and 08/31/2022.
  • Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.

You may not qualify if:

  • \- Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des maladies infectieuses et tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations