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
PHARIBO
1 other identifier
interventional
506
1 country
26
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Shorter than P25 for not_applicable
26 active sites
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
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 12, 2025
CompletedStudy Start
First participant enrolled
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
September 1, 2026
August 1, 2026
6 months
August 5, 2025
August 27, 2026
Conditions
Keywords
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
EXPERIMENTALwoman, between 18 and 65 years, coming to a pharmacy randomized in the experimental group for symptom of acute cystitis without risk of complication
Delegation protocol alone group
ACTIVE COMPARATORwoman, between 18 and 65 years, coming to a pharmacy randomized in the control group for symptom of acute cystitis without risk of complication
Interventions
the control group will apply the delegation protocol alone
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
Eligibility Criteria
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 (26)
Pharmacie Lemarquis
Aire-sur-l'Adour, 40800, France
Pharmacie Lafitte
Arès, 33740, France
Pharmacie de Bon Encontre
Bon-Encontre, France
CHU de Bordeaux
Bordeaux, France
Pharmacie de Castets et Castillon
Castets Et Castillon, France
Pharmacie Pattyn Nizard
Caudebec-lès-Elbeuf, 76320, France
Pharmacie du mortier d'Or
Caudebec-lès-Elbeuf, France
Pharmacie des 3 vallées
Creysse, France
Pharmacie Saint-Jean d'Elbeuf
Elbeuf, 76500, France
Pharmacie Tranchant
Elbeuf, 76500, France
Pharmacie du Réolais
La Réole, 33190, France
Pharmacie Bougniot
Labouheyre, France
Pharmacie de Gascogne
Léguevin, 31490, France
Pharmacie de l'Hotel de Ville
Malaunay, 76770, France
Pharmacie de la Sèvre
Moncoutant Sur Sèvre, France
Pharmacie du Pontreau
Niort, 79000, France
Pharmacie Centrale
Plouha, 22580, France
Pharmacie des Grandes Vignes
Preignac, 33210, France
Pharmacie Puymirol
Puymirol, France
Pharmacie de Saint-Ouen
SAINT-OUEN-de-thouverville, France
Pharmacie du Château
Saint-Porchaire, France
Pharmacie des Jacobins
Saint-Sever, 40500, France
Pharmacie du Cap de Gascogne
Saint-Sever, France
Pharmacie de Bellevue
Saintes, 17100, France
Pharmacie de l'Olympia
Saintes, France
Pharmacie Lagoueyte
Soustons, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
August 5, 2025
First Posted
August 12, 2025
Study Start
May 19, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
September 1, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share