Acute CystitisPHARIBONCT07118748
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
A study testing Share making decision tool and Delegation protocol in people with Acute Cystitis, run by University Hospital, Bordeaux at 26 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Acute Cystitis
- What is being tested?
- Share making decision tool and Delegation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 26 sitesFrance
- Study dates
- 19 May 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- woman,
- symptom of acute cystitis without risk of complication,
- affiliated to the french public welfare system,
- signed consent.
Who cannot join
- anomaly of the urinary canal,
- pregnancy, more than 3 cystitis during the last year,
- cancer,
- immunosuppression,
- hemopathy,
- fever,
Show all 10Show fewer
- back-pain,
- severe renal failure,
- refuse to give consent and previously participate to the study,
- under guardianship.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
France26 sites, 26 recruiting
- Recruiting
Pharmacie Lemarquis
Aire-sur-l'Adour, 40800
Paul LEMARQUIS, 05.58.71.60.59 ext. +33, pharmacie.lemarquis@gmail.com
Paul LEMARQUIS
- Recruiting
Pharmacie Lafitte
Arès, 33740
Mathilde QUERAUX, 05.56.60.24.39 ext. +33, phie.laffitte@orange.fr
Mathilde QUERAUX
- Recruiting
Pharmacie de Bon Encontre
Bon-Encontre
Nicolas De BOURY, 05 53 96 07 12 ext. +33, pharmaciedebonencontre@outlook.fr
Nicolas De BOURY
- Recruiting
CHU de Bordeaux
Bordeaux
Yves-Marie VINCENT, MD, 05 57 57 13 11, yves-marie.vincent@u-bordeaux.fr
Pierre POULIZAC, 05.57.82.08.49, pierre.poulizac@chu-bordeaux.fr
- Recruiting
Pharmacie de Castets et Castillon
Castets Et Castillon
Lisa SEBAIHI, 5 56 62 83 21 ext. +33, pharmacie.decastets@gmail.com
Lisa SEBAIHI
- Recruiting
Pharmacie Pattyn Nizard
Caudebec-lès-Elbeuf, 76320
Laurence PATTYN-NIZARD, 02.35.77.06.79 ext. +33, ordonnances@pharmapattyn.fr
Laurence PATTYN-NIZARD
- Recruiting
Pharmacie du mortier d'Or
Caudebec-lès-Elbeuf
Romain THIEUBAUT, 02 35 77 03 57 ext. +33, pro.pharmaciedumortierdor@gmail.com
Romain THIEUBAUT
- Recruiting
Pharmacie des 3 vallées
Creysse
Boris BROUILLET, 05 53 23 21 11 ext. +33, pharmaciedes3vallees@yahoo.com
Boris BROUILLET
- Recruiting
Pharmacie Saint-Jean d'Elbeuf
Elbeuf, 76500
Valérie QUICHON, 02.35.77.09.97 ext. +33, pharmacie.saintjean-elbeuf@orange.fr
Valérie QUICHON
- Recruiting
Pharmacie Tranchant
Elbeuf, 76500
Angélique TRANCHANT, 02.35.77.01.26 ext. +33, pharmacie.tranchant@gmail.com
Angélique TRANCHANT
- Recruiting
Pharmacie du Réolais
La Réole, 33190
Vincent VAZQUEZ, 05.56.61.01.60 ext. +33, vincent.vazquez@gmail.com
Vincent VAZQUEZ
- Recruiting
Pharmacie Bougniot
Labouheyre
Marc DEVARIEUX, 5 58 07 00 13 ext. +33, ph.marcdevarieux@gmail.com
Marc DEVARIEUX
- Recruiting
Pharmacie de Gascogne
Léguevin, 31490
Christine GESTAS, 05.61.86.60.47 ext. +33, pharmaciedegascogne@wanadoo.fr
Christine GESTAS
- Recruiting
Pharmacie de l'Hotel de Ville
Malaunay, 76770
Etienne PELEGRIN, 02.35.74.10.55, Pharmacie.malaunay@orange.fr
Etienne PELEGRIN
- Recruiting
Pharmacie de la Sèvre
Moncoutant Sur Sèvre
Estelle DELABROYE, 5 49 72 60 24 ext. +33, edelabroye@totum.fr
Estelle DELABROYE
- Recruiting
Pharmacie du Pontreau
Niort, 79000
Patrick LE PADELLEC, 05.49.24.04.08 ext. +33, contact@pharmaciedupontreau.com
Patrick LE PADELLEC
- Recruiting
Pharmacie Centrale
Plouha, 22580
Angélique CHAPELAIN-FILLATRE, 02.96.22.41.77 ext. +33, chapelainroche@gmail.com
Angélique CHAPELAIN-FILLATRE
- Recruiting
Pharmacie des Grandes Vignes
Preignac, 33210
Marlène GERARD, 05.56.63.27.42 ext. +33, pharmaciedepreignac@gmail.com
Marlène GERARD
- Recruiting
Pharmacie Puymirol
Puymirol
Mary-Luz RENAUD, Dr, 9 66 11 14 27 ext. +33, pharmaciepuymirol@gmail.com
Mary-Luz RENAUD
- Recruiting
Pharmacie de Saint-Ouen
SAINT-OUEN-de-thouverville
Morgane LEFEBVRE, 02 32 56 26 48 ext. +33, pharmaciedesaintouen@orange.fr
Morgane LEFEBVRE
- Recruiting
Pharmacie du Château
Saint-Porchaire
Alexandre PEYRIDIEUX, 5 46 95 60 25 ext. +33, alexandre@peyridieux.com
Alexandre PEYRIDIEUX
- Recruiting
Pharmacie des Jacobins
Saint-Sever, 40500
Prunelle TAIEB, 05.58.76.00.39 ext. +33, pharmadesjacobins@gmail.com
Prunelle TAIEB
- Recruiting
Pharmacie du Cap de Gascogne
Saint-Sever
Lisa FALLET, 5 58 76 01 29 ext. +33, pharmacieducap@gmail.com
Lisa FALLET
- Recruiting
Pharmacie de Bellevue
Saintes, 17100
Cyrille PRINCE, 05.46.93.15.88 ext. +33, pharmaciebellevue01@gmail.com
Cyrille PRINCE
- Recruiting
Pharmacie de l'Olympia
Saintes
Charlotte CERTIN, 5 46 74 37 51 ext. +33, chacertin@msn.com
Charlotte CERTIN
- Recruiting
Pharmacie Lagoueyte
Soustons
Marc PRUJA, 5 58 41 51 69 ext. +33, marco4064@yahoo.fr
Marc PRUJA
About this study
Official title: Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool : a Randomised Cluster Trial. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections
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.
Read the detailed description
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
- Acute Cystitis
- Being tested
- Share making decision tool, Delegation protocol
- Keywords
- cystitis, professional delegation, share decision making, antibiotics
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Delegation protocolOther
the control group will apply the delegation protocol alone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Delegation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dispensing of antibiotic
Dispensing of antibiotic for acute cystitis without risk of complication on the 14 days following the first visit to the pharmacy.
Measured: day 14 after inclusion
Secondary outcomes (4)
Activity Impairment Assessment(AIA) scale
5-item ranging from 0 (no impact) to 4 (constant impact). It has no sub-dimensions and allows for an overall assessment (sum of the scores for each item) ranging from 0 (no discomfort/no incapacity) to 20 (total discomfort/ total incapacity).
Measured: day 14 after inclusion
Satisfaction scale
Satisfaction score on a scale from 0 (dissatisfaction) to 10 (total satisfaction)
Measured: day 14 after inclusion
O'Connor scale
16-item scale rated from 1 to 5. Each score is converted to a base of 100 (1=0, 5=100).
The total average of the items out of 100 determines:
< 25: Low conflict - the person is probably ready to make a decision. 25-37.5: Moderate conflict - some discomfort may still exist.
≥ 37.5: High conflict - the person probably needs help deciding.
Measured: day 14 after inclusion
Medical consultation
Consultations with a doctor or at the emergency room for urinary tract infection and/or possible complications among patients diagnosed with uncomplicated cystitis within two weeks of visiting the pharmacy (telephone survey at two weeks).
Measured: day 14 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start19 May 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CystitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, two-arms cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118748
- Sponsor's protocol ID
- CHUBX 2024/66
- Acronym
- PHARIBO
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool : a Randomised Cluster Trial. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT07118748
- Acronym / sponsor ID
- PHARIBO / CHUBX 2024/66
- Conditions
- Acute Cystitis
- Keywords
- cystitis, professional delegation, share decision making, antibiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, two-arms cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Share making tool decision group | Experimental | Other: Share making decision toolwoman, 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 comparator | Other: Delegation protocolwoman, between 18 and 65 years, coming to a pharmacy randomized in the control group for symptom of acute cystitis without risk of complication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- woman,
- symptom of acute cystitis without risk of complication,
- affiliated to the french public welfare system,
- signed consent.
Key exclusion criteria (10 listed)
- anomaly of the urinary canal,
- pregnancy, more than 3 cystitis during the last year,
- cancer,
- immunosuppression,
- hemopathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Share making decision toolthe 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 | Other | Share making tool decision group |
| Delegation protocolthe control group will apply the delegation protocol alone | Other | Delegation protocol alone group |
Primary outcome
Dispensing of antibiotic
Time frame: day 14 after inclusion
Dispensing of antibiotic for acute cystitis without risk of complication on the 14 days following the first visit to the pharmacy.
4 secondary outcomes
Activity Impairment Assessment(AIA) scale
Time frame: day 14 after inclusion
Satisfaction scale
Time frame: day 14 after inclusion
O'Connor scale
Time frame: day 14 after inclusion
Medical consultation
Time frame: day 14 after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Share making decision tool and Delegation protocol in people with Acute Cystitis, run by University Hospital, Bordeaux at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves-Marie VINCENT, MD (05 57 57 13 11, yves-marie.vincent@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dispensing of antibiotic (time frame: day 14 after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.