NCT06218277

Brief Summary

The investigators want to investigate the clinical impact of early antimicrobial susceptibility results for gram negative bacilli isolated from blood cultures on antimicrobial choices and early switches of antimicrobial therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 18, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

December 18, 2023

Last Update Submit

September 5, 2024

Conditions

Bacteremia

Outcome Measures

Primary Outcomes (1)

  • Time tot first effective antibiotic therapy

    Time tot first effective antibiotic therapy

    24 hours

Secondary Outcomes (4)

  • Time to optimal antibiotic therapy

    72 hours

  • Number of different antibiotic classes used in treatment

    14 days

  • Time to stop antibiotic therapy

    14 days

  • Time of empiric treatment

    72 hours

Study Arms (1)

ASTAR

EXPERIMENTAL

Use of the early AST results for guidance of the antimicrobial therapy

Diagnostic Test: ASTAR

Interventions

ASTARDIAGNOSTIC_TEST

Rapid AST with ASTAR

ASTAR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with blood culture positive with gram negative bacilli

You may not qualify if:

  • Mixed blood culture positivity on Gram stain
  • Positive blood culture with gram negative bacilli in the previous 7 days
  • Life expectancy of \< 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Messiaen AS, Vandendriessche S, De Muynck E, Strubbe G, De Bus L, Schelstraete P, Decommer K, De Smet S, Soetens A, Naesens L, Timmermans K, De Waele JJ, Veld DHI', Boelens J. Impact of reporting rapid susceptibility results in Gram negative bloodstream infections: a real world prospective study. Eur J Clin Microbiol Infect Dis. 2025 Apr;44(4):847-853. doi: 10.1007/s10096-025-05046-3. Epub 2025 Jan 25.

    PMID: 39862301DERIVED

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jerina Boelens

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective in one group of patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 23, 2024

Study Start

January 10, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)