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
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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NOT_YET_RECRUITING
NA
506 participants
INTERVENTIONAL
2026-03-31
2026-10-31
Brief Summary
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This will select patients in need of antibiotics and preserve the full-capacities of non-treated one.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
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
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
Delegation protocol
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
Delegation protocol
the control group will apply the delegation protocol alone
Eligibility Criteria
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Inclusion Criteria
* symptom of acute cystitis without risk of complication,
* affiliated to the french public welfare system,
* signed consent.
Exclusion Criteria
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU de Bordeaux
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2024/66
Identifier Type: -
Identifier Source: org_study_id
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