NCT05535751

Brief Summary

Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

September 6, 2022

Last Update Submit

December 12, 2023

Conditions

Bacteremia

Keywords

BacteremiaCefepimecarbapenemsAmpC β-lactamaseenterobacteriaceae bloodstream infections

Outcome Measures

Primary Outcomes (1)

  • Hospital mortality

    30 days after infection

Eligibility Criteria

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

Adult patient (≥18 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia

You may qualify if:

  • Adult patient (≥18 years of age)
  • managed within a study center for high-grade cephalosporinase-producing bacteremia
  • Not objecting to the reuse of their health data for scientific research purposes.

You may not qualify if:

  • Patient who has expressed opposition to the reuse of their data for scientific research purposes.
  • Resistance to Cefepime or carbapenems
  • Multiple bacteremia
  • Treatment with a molecule other than Cefepime or carbapenem.

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

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 10, 2022

Study Start

July 20, 2022

Primary Completion

May 20, 2023

Study Completion

June 20, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

FR(1)