Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections

NCT ID: NCT07118748

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Each year, in France, more than 2.000.000 patients visit for a acute cystitis. The literature shows that acute cystitis without risk of complication cause pyelonephritis only on really rare situation, but french delegation protocols to pharmacist ask for systematic antibiotic therapy as soon as the diagnostic is made with the only goal to lowering symptomatology. Studies shows that some informed women would like not to take antibiotics while others studies show us that pain-killers could be as effective as antibiotics on case of low symptomatology.

This study will compare a group following only the French protocols for delegating acute cystitis to the pharmacist with a group using the same protocol, but supplementing it with a shared decision-making tool to determine whether, after being informed of the benefits and risks of this treatment, patients still wish to receive an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.

After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get informations (antibiotic prescription or not, patient socio-demographic criteria). Then patients will be followed by telephone on D14 to know if they've take antibiotics and to obtain the following information: AIA scale, O'Connor Scale, Satisfaction scale, if there has been visit to the emergency room or doctor. Antibiotics delivery on pharmacy will be watch by National assurance number of the included patients

Conditions

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Acute Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open-label, two-arms cluster randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Share making tool decision group

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

Group Type EXPERIMENTAL

Share making decision tool

Intervention Type OTHER

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

Delegation protocol alone group

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

Group Type ACTIVE_COMPARATOR

Delegation protocol

Intervention Type OTHER

the control group will apply the delegation protocol alone

Interventions

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Share making decision tool

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

Intervention Type OTHER

Delegation protocol

the control group will apply the delegation protocol alone

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* woman,
* symptom of acute cystitis without risk of complication,
* affiliated to the french public welfare system,
* signed consent.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Central Contacts

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Yves-Marie VINCENT, MD

Role: CONTACT

05 57 57 13 11

Pierre POULIZAC

Role: CONTACT

05.57.82.08.49

Facility Contacts

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Yves-Marie VINCENT, MD

Role: primary

05 57 57 13 11

Pierre POULIZAC

Role: backup

05.57.82.08.49

Other Identifiers

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CHUBX 2024/66

Identifier Type: -

Identifier Source: org_study_id

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