NCT07118748

Brief Summary

The purpose of this trial is to demonstrate that when treating acute cystitis without risk of complication, pharmacists may use share Decision Making tool to help patients to better understand the stakes of taking antibiotics and adapt the management of the delegation protocol. This will select patients in need of antibiotics and preserve the full-capacities of non-treated one.

Trial Health

63
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Trial Health Score

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

Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

14 active sites

Status
not yet recruiting

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

Study Progress32%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

August 5, 2025

Last Update Submit

March 19, 2026

Conditions

Acute Cystitis

Keywords

cystitisprofessional delegationshare decision makingantibiotics

Outcome Measures

Primary Outcomes (1)

  • Dispensing of antibiotic

    Dispensing of antibiotic for acute cystitis without risk of complication on the 14 days following the first visit to the pharmacy.

    day 14 after inclusion

Secondary Outcomes (4)

  • Activity Impairment Assessment(AIA) scale

    day 14 after inclusion

  • Satisfaction scale

    day 14 after inclusion

  • O'Connor scale

    day 14 after inclusion

  • Medical consultation

    day 14 after inclusion

Study Arms (2)

Share making tool decision group

EXPERIMENTAL

woman, between 18 and 65 years, coming to a pharmacy randomized in the experimental group for symptom of acute cystitis without risk of complication

Other: Share making decision tool

Delegation protocol alone group

ACTIVE COMPARATOR

woman, between 18 and 65 years, coming to a pharmacy randomized in the control group for symptom of acute cystitis without risk of complication

Other: Delegation protocol

Interventions

Share making decision toolOTHER

the experimental group will apply the delegation protocol, but if the protocol recommends antibiotic therapy, the researchers will propose a shared decision using a specific tool to determine with the patient whether to deliver the antibiotic

Share making tool decision group
Delegation protocolOTHER

the control group will apply the delegation protocol alone

Delegation protocol alone group

Eligibility Criteria

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

You may qualify if:

  • woman,
  • symptom of acute cystitis without risk of complication,
  • affiliated to the french public welfare system,
  • 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 (14)

Pharmacie Lemarquis

Aire-sur-l'Adour, 40800, France

Location

Pharmacie Lafitte

Arès, 33740, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Pharmacie Pattyn Nizard

Caudebec-lès-Elbeuf, 76320, France

Location

Pharmacie Saint-Jean d'Elbeuf

Elbeuf, 76500, France

Location

Pharmacie Tranchant

Elbeuf, 76500, France

Location

Pharmacie du Réolais

La Réole, 33190, France

Location

Pharmacie de Gascogne

Léguevin, 31490, France

Location

Pharmacie de l'Hotel de Ville

Malaunay, 76770, France

Location

Pharmacie du Pontreau

Niort, 79000, France

Location

Pharmacie Centrale

Plouha, 22580, France

Location

Pharmacie des Grandes Vignes

Preignac, 33210, France

Location

Pharmacie des Jacobins

Saint-Sever, 40500, France

Location

Pharmacie de Bellevue

Saintes, 17100, France

Location

MeSH Terms

Conditions

Cystitis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yves-Marie VINCENT, MD

CONTACT

05 57 57 13 11yves-marie.vincent@u-bordeaux.fr

Pierre POULIZAC

CONTACT

05.57.82.08.49pierre.poulizac@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: open-label, two-arms cluster randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(14)