NCT04272281

Brief Summary

the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

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

February 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

February 14, 2020

Last Update Submit

March 8, 2022

Conditions

Cystitis

Keywords

primary health careshare decision makingantibioticsdaily activities

Outcome Measures

Primary Outcomes (1)

  • Use of antibiotic for acute cystitis without risk of complication

    Day 14 after inclusion (day 0)

Secondary Outcomes (3)

  • Score at the "Activity Impairment Assessment" scale

    Day 0, Day 5 and Day14

  • Score at the satisfaction scale

    Day 0, Day 5, Day14 and Day 90

  • Recurrence of the infection

    Between Day 15 and Day 90

Study Arms (2)

Share making tool decision

EXPERIMENTAL

Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy

Procedure: medical shared decision

Standard recommandation

ACTIVE COMPARATOR

Patients recruited from general practitioner will receive the standard medical care

Procedure: Standard medical care

Interventions

medical shared decisionPROCEDURE

The experimental group will use the share decision making tool during consultation to adapt antibiotherapy

Share making tool decision
Standard medical carePROCEDURE

control group will act as usual in their practice.

Standard recommandation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • woman
  • between 18 and 65 years
  • symptom of acute cystitis without risk of complication
  • affiliated to the French public welfare system
  • with signed consent

You may not qualify if:

  • anomaly of the urinary canal
  • pregnancy
  • more than 3 cystitis during the last year
  • cancer, immunosuppression
  • hemopathy, fever
  • back-pain
  • severe renal failure
  • refuse to give consent and previously participate to the study
  • under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Cystitis

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 17, 2020

Study Start

July 22, 2020

Primary Completion

December 3, 2021

Study Completion

February 17, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)