NCT05140213

Brief Summary

Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

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

December 12, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 23, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 17, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

Adult patientsProbabilistic antibiotic therapy to be initiated

Outcome Measures

Primary Outcomes (1)

  • Numbers of patient 30-day mortality

    patient survival at 30 days

    30 day

Other Outcomes (2)

  • Numbers of patient 90-day mortality

    90 days

  • Numbers of patient 6 months mortality

    6 months

Study Arms (2)

Group 1 : Before

"Before" phase including 186 patients patients included before the implementation of the prescription support tool

Device: Anti-infectious prescription support tool

Group 2 : After

"After" phase including 185 patients patients included after the implementation of the prescription support tool

Device: Anti-infectious prescription support tool

Interventions

implementation of a pocket notebook with current anti-infectious recommendations in the emergency department Patients were kept under surveillance for at least one hour before discharge. Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6 h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief.

Group 1 : BeforeGroup 2 : After

Eligibility Criteria

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

Major patients with severe sepsis in the Montpellier emergency department

You may qualify if:

  • Major patients
  • Sepsis or septic shock
  • Oral consent

You may not qualify if:

  • minor patients
  • death before antibiotherapy
  • care limitations
  • pre-hospital antibiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Hamza GHOMRANI, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 1, 2021

Study Start

December 12, 2020

Primary Completion

August 12, 2021

Study Completion

August 30, 2021

Last Updated

December 23, 2021

Record last verified: 2021-11

Locations