NCT03928951

Brief Summary

Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments. This will allow assessing the quality of initial antibiotic prescription and help to improve practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

April 24, 2019

Last Update Submit

November 27, 2019

Conditions

Keywords

Urinary infectionsAntibiotherapyEmergencyReassessment

Outcome Measures

Primary Outcomes (1)

  • Rate of antibiotherapies modified by general practitioners

    Number of antibiotic prescriptions modified by general practitioners divided by the total number of initial antibiotic prescriptions

    6 months

Secondary Outcomes (5)

  • Rate of initial antibiotherapies not relevant to recommendations

    6 months

  • Rate of initial antibiotherapies not consistent with recommendations

    6 months

  • Rate of reassessments not relevant to recommendations

    6 months

  • Rate of reassessments not consistent with recommendations

    6 months

  • Frequence of use of shared medical file

    6 months

Study Arms (1)

Patients suffering from urinary infection

Patients consulting in one of Toulon - La Seyne sur Mer hospital emergency departments because of urinary infection

Other: General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments

Interventions

Antibiotherapy will be prescribed by emergency physicians and general practitioners will be contacted 4 to 5 days later to know if antibiotherapy was modified

Patients suffering from urinary infection

Eligibility Criteria

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

Patients consulting in emergency departments of Toulon La Seyne sur Mer hospital because of a urinary infection and to whom antibiotherapy is prescribed

You may qualify if:

  • Every patient more than 18 years who was administered antibiotherapy for urinary infection in emergency department or for whom urinary infection was diagnosed in emergency department (cystitis, acute pyelonephritis, prostatitis)

You may not qualify if:

  • Patients less than 18 years old
  • Patients opposed to their data use
  • Patients hospitalized more than 24 hours
  • Patients taking antibiotherapy already before their arrival in emergency department
  • Patients without sufficient reading capacities or understanding of french language to express opposition to their research participation
  • Any other reason which, according to investigator, might interfere with research objective evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, Var, 83056, France

Location

MeSH Terms

Conditions

Urinary Tract InfectionsEmergencies

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mouna EL OMRI, MD

    Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

June 14, 2019

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations