Cystitis AcutePharmaCyst'NCT05510128
Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs
A study testing Pharmacist management in people with Cystitis Acute, run by University Hospital, Angers at 14 sites in France.
Trial summary
Every year, between 4 and 6 million French people are affected by a urinary infection; the vast majority of these are women. Although the diagnosis of an uncomplicated urinary tract infection is simple to make, it requires prompt medical management to relieve the symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cystitis Acute
- What is being tested?
- Pharmacist management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 14 sitesFrance
- Study dates
- 30 Jun 2023to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female
- Age ≥ 18 and <65 years
- Patient with less than 3 days of simple urinary tract infection symptoms:
- Burning, pain on urination
- Dysuria
- Pollakiuria
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- Urinary urgency
- Patient affiliated or beneficiary of a social insurance
- Patient having signed an informed consent.
Who cannot join
- More than 3 cystitis in the last 12 months;
- Last cystitis less than 15 days old;
- Presence of fever;
- Presence of back pain;
- Presence of a functional or organic anomaly of the urinary tract (bladder residue, vesico-ureteral reflux, lithiasis, tumor);
- Pruritus or vaginal discharge;
Show all 23Show fewer
- Vomiting, diarrhea, diffuse abdominal pain;
- Risk factors for C3G-resistant enterobacteria infection (grade B):
- Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G, fluoroquinolones) within the previous 3 months;
- A nosocomial or healthcare-associated infection;
- A history of colonization or infection with C3G-resistant enterobacteria within the last 3 months;
- A trip to a foreign country within the last 3 months in known geographical areas at risk (in particular the Indian subcontinent, South-East Asia, the Middle East and North Africa, the Mediterranean basin);
- Hospitalization within 3 months;
- Hospitalization within 6 months for UTI;
- Known severe renal insufficiency (creatinine clearance < 30 mL/min);
- Severe immunosuppression or immunosuppressive treatments;
- Contraindications to drugs planned for experimental management (pivmecillinam and fosfomycin) or combination of drugs not recommended;
- Pregnant women (confirmed or suspected pregnancy), breastfeeding women or women in labour;
- Person deprived of liberty by judicial or administrative decision;
- Person under forced psychiatric care;
- Person admitted to a health or social institution for purposes other than research;
- Person subject to a legal protection measure;
- A person who is unable to give consent.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Pharmacie du Pays De Retz
Bourgneuf-en-Retz, 44580
Pharmacie de Brûlon
Brûlon
Pharmacie Degueille
Chemazé
Pharmacie Nicolleau-Dilé
Chemillé-Melay, 49120
Pharmacie des Halles
Craon
Pharmacie de la Place
La Ferté-Bernard
Pharmacie de la Pointe
Le Mans
Pharmacie du Centre
Le May-sur-Èvre
Pharmacie du Louet
Mûrs-Erigné
Pharmacie des Arcades
Nozay
Pharmacie Deroche
Roézé-sur-Sarthe
Pharmacie Llacuna
Sainte-Anne-sur-Brivet
Pharmacie du Chemin Vert
Saumur
Pharmacie de la Source
Sougé-le-Ganelon
About this study
Official title: Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies
Every year, between 4 and 6 million French people are affected by a urinary infection; the vast majority of these are women. Although the diagnosis of an uncomplicated urinary tract infection is simple to make, it requires prompt medical management to relieve the symptoms. The lack of immediate of a physician can slow down the management of patients affected by this condition, and lead to an inappropriate referral of patients to the emergency services.
Because of their wide availability, accessibility, and geographical distribution throughout the country, pharmacists are primary health care professionals who are regularly called upon to respond to patients with this type of infection.
A national protocol exists in France, but it is very difficult to apply. The PharmaCyst' study aims to evaluate its application in community pharmacies.
- Conditions
- Cystitis Acute
- Being tested
- Pharmacist management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist managementOther
When a patient comes to the pharmacy with signs of urinary burning, the following will follow:
- Completion of the acute cystitis symptoms score (ACSS) questionnaire.
- Measure the temperature.
- Perform a urine dipstick.
If the patient's temperature is normal, the urine dipstick is positive, and the absence of pain in the lumbar fossa is verified, the pharmacist can dispense an appropriate antibiotic himself. A reminder of the hygienic-dietary rules is also issued, and a communication to the patient's general practitioner will be made.
| Study group | Role | What they receive |
|---|---|---|
| Management with the protocol | Experimental | Patients who participate in the study in the experimental arm benefit from an adapted management, which falls under the application of the national cooperation protocol.
This management may lead to the dispensing of an antibiotic by the pharmacist himself. Receives: Other: Pharmacist management |
| Standard care | No intervention | Patients participating in the study in the control arm will benefit from a management comparable to the current one. In addition to a reminder of the hygienic and dietary rules by the pharmacist, the patient may be offered a drug indicated for improving urinary comfort. The pharmacist should also remind the patient that she can consult a doctor, especially in case of non relief or aggravation of symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evolution of the symptoms at D3
Difference in the score from the first part of the Acute Cystitis Symptome Score questionnaire. The minimum value is 0 and the maximun value is 18. A higher score mean worse outcome
Measured: Enrollment, Day 3
Secondary outcomes (11)
The evolution of the symptoms at D10
Difference in the score from the first part of the Acute Cystitis Symptome Score questionnaire. The minimum value is 0 and the maximun value is 18. A higher score mean worse outcome
Measured: Enrollment, Day 10
Use of a medical consultation or an emergency service
Number of consultations provided
Measured: At 3 days
Use of a medical consultation or an emergency service
Nature of consultations provided
Measured: At 10 days
Performing a urine dipstick
Number of urine dipstick performed
Measured: Enrollment, Day 3, Day 10
Performing a urine culture
Number of urine culture performed
Measured: At 3 days and 10 days
Taking medication to relieve the symptoms of the infection
Number of medication used
Measured: Enrollment,
Taking medication to relieve the symptoms of the infection
Nature of medication used
Measured: Day 3,
Taking medication to relieve the symptoms of the infection
Nature of medication used
Measured: Day 10
Occurrence of an adverse event at D3 and D10
Number of adverse events
Measured: At 10 days
Occurrence of an adverse event at D3 and D10
Nature of adverse events
Measured: At 3 days
Recurrence of a urinary tract infection within 3 months (M3)
Number of cystitis encountered
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start30 Jun 2023
- Primary completion29 Oct 2024
- Study completion29 Jan 2025
Why it stopped: A premature termination was decided following the publication of the order authorizing the pharmacist to dispense antibiotics for simple cystitis in women. Thus the experimental practice of the study joins very strongly with the new practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sébastien Faure, Professor, Principal investigator, Angers UniversityAline Ramond-Roquin, Professor, Study director, Angers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510128
- Sponsor's protocol ID
- 49RC22_0240
- Acronym
- PharmaCyst'
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies
- ClinicalTrials.gov ID
- NCT05510128
- Acronym / sponsor ID
- PharmaCyst' / 49RC22_0240
- Conditions
- Cystitis Acute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A premature termination was decided following the publication of the order authorizing the pharmacist to dispense antibiotics for simple cystitis in women. Thus the experimental practice of the study joins very strongly with the new practice.
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 22 Aug 2022 (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.
Every year, between 4 and 6 million French people are affected by a urinary infection; the vast majority of these are women. Although the diagnosis of an uncomplicated urinary tract infection is simple to make, it requires prompt medical management to relieve the symptoms. The lack of immediate of a physician can slow down the management of patients affected by this condition, and lead to an inappropriate referral of patients to the emergency services.
Because of their wide availability, accessibility, and geographical distribution throughout the country, pharmacists are primary health care professionals who are regularly called upon to respond to patients with this type of infection.
A national protocol exists in France, but it is very difficult to apply. The PharmaCyst' study aims to evaluate its application in community pharmacies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Management with the protocol | Experimental | Other: Pharmacist managementPatients who participate in the study in the experimental arm benefit from an adapted management, which falls under the application of the national cooperation protocol. This management may lead to the dispensing of an antibiotic by the pharmacist himself. |
| Standard care | No intervention | –Patients participating in the study in the control arm will benefit from a management comparable to the current one. In addition to a reminder of the hygienic and dietary rules by the pharmacist, the patient may be offered a drug indicated for improving urinary comfort. The pharmacist should also remind the patient that she can consult a doctor, especially in case of non relief or aggravation of symptoms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age ≥ 18 and <65 years
- Patient with less than 3 days of simple urinary tract infection symptoms:
- Patient affiliated or beneficiary of a social insurance
- Patient having signed an informed consent.
Key exclusion criteria (23 listed)
- More than 3 cystitis in the last 12 months;
- Last cystitis less than 15 days old;
- Presence of fever;
- Presence of back pain;
- Presence of a functional or organic anomaly of the urinary tract (bladder residue, vesico-ureteral reflux, lithiasis, tumor);
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 |
|---|---|---|
| Pharmacist managementWhen a patient comes to the pharmacy with signs of urinary burning, the following will follow: * Completion of the acute cystitis symptoms score (ACSS) questionnaire. * Measure the temperature. * Perform a urine dipstick. If the patient's temperature is normal, the urine dipstick is positive, and the absence of pain in the lumbar fossa is verified, the pharmacist can dispense an appropriate antibiotic himself. A reminder of the hygienic-dietary rules is also issued, and a communication to the patient's general practitioner will be made. | Other | Management with the protocol |
Primary outcome
The evolution of the symptoms at D3
Time frame: Enrollment, Day 3
Difference in the score from the first part of the Acute Cystitis Symptome Score questionnaire. The minimum value is 0 and the maximun value is 18. A higher score mean worse outcome
11 secondary outcomes
The evolution of the symptoms at D10
Time frame: Enrollment, Day 10
Use of a medical consultation or an emergency service
Time frame: At 3 days
Use of a medical consultation or an emergency service
Time frame: At 10 days
Performing a urine dipstick
Time frame: Enrollment, Day 3, Day 10
Performing a urine culture
Time frame: At 3 days and 10 days
Taking medication to relieve the symptoms of the infection
Time frame: Enrollment,
Taking medication to relieve the symptoms of the infection
Time frame: Day 3,
Taking medication to relieve the symptoms of the infection
Time frame: Day 10
Occurrence of an adverse event at D3 and D10
Time frame: At 10 days
Occurrence of an adverse event at D3 and D10
Time frame: At 3 days
Recurrence of a urinary tract infection within 3 months (M3)
Time frame: At 3 months
Results and safety
The study was stopped early (reason given: A premature termination was decided following the publication of the order authorizing the pharmacist to dispense antibiotics for simple cystitis in women. Thus the experimental practice of the study joins very strongly with the new practice.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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. This study is not recruiting at the moment.
Sébastien Faure, Professor principal investigator
Angers University
Aline Ramond-Roquin, Professor study director
Angers University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist management in people with Cystitis Acute, run by University Hospital, Angers at 14 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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study was stopped early (reason given: A premature termination was decided following the publication of the order authorizing the pharmacist to dispense antibiotics for simple cystitis in women. Thus the experimental practice of the study joins very strongly with the new practice.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evolution of the symptoms at D3 (time frame: Enrollment, Day 3). 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 13 Mar 2026.