Clinical trial NCT05510128: Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs
Official title: Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystitis Acute
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Directorate General for Health Care Provision
name: Regional Union of Health Professionals - Pharmacists, Pays de la Loire Region
name: Regional Health Agency, Pays de la Loire Region
First posted: 2022-08-22
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥ 18 and \<65 years
* Patient with less than 3 days of simple urinary tract infection symptoms:

  * Burning, pain on urination
  * Dysuria
  * Pollakiuria
  * Urinary urgency
* Patient affiliated or beneficiary of a social insurance
* Patient having signed an informed consent.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: The evolution of the symptoms at D3
timeFrame: Enrollment, Day 3
Secondary outcomes:
measure: The evolution of the symptoms at D10
timeFrame: Enrollment, Day 10
measure: Use of a medical consultation or an emergency service
timeFrame: At 3 days
measure: Use of a medical consultation or an emergency service
timeFrame: At 10 days
measure: Performing a urine dipstick
timeFrame: Enrollment, Day 3, Day 10
measure: Performing a urine culture
timeFrame: At 3 days and 10 days
measure: Taking medication to relieve the symptoms of the infection
timeFrame: Enrollment,
measure: Taking medication to relieve the symptoms of the infection
timeFrame: Day 3,
measure: Taking medication to relieve the symptoms of the infection
timeFrame: Day 10
measure: Occurrence of an adverse event at D3 and D10
timeFrame: At 10 days
measure: Occurrence of an adverse event at D3 and D10
timeFrame: At 3 days
measure: Recurrence of a urinary tract infection within 3 months (M3)
timeFrame: At 3 months
Other outcomes:
measure: Patients' satisfaction
timeFrame: At 10 days
measure: Patients' care overall satisfaction
timeFrame: At 10 days
measure: Pharmacists' satisfaction
timeFrame: through study completion, an average of 12 months
measure: Pharmacists' experience
timeFrame: through study completion, an average of 12 months
Locations:
city: Bourgneuf-en-retz
country: France
facility: Pharmacie du Pays De Retz
city: Brûlon
country: France
facility: Pharmacie de Brûlon
city: Chemazé
country: France
facility: Pharmacie Degueille
city: Chemillé-Melay
country: France
facility: Pharmacie Nicolleau-Dilé
city: Craon
country: France
facility: Pharmacie des Halles
city: La Ferté-Bernard
country: France
facility: Pharmacie de la Place
city: Le Mans
country: France
facility: Pharmacie de la Pointe
city: Le May-sur-Èvre
country: France
facility: Pharmacie du Centre
city: Mûrs-Erigné
country: France
facility: Pharmacie du Louet
city: Nozay
country: France
facility: Pharmacie des Arcades
city: Roeze-sur-sarthe
country: France
facility: Pharmacie Deroche
city: Sainte-anne Sur Brivet
country: France
facility: Pharmacie Llacuna
city: Saumur
country: France
facility: Pharmacie du Chemin Vert
city: Sougé-le-Ganelon
country: France
facility: Pharmacie de la Source
Study officials:
affiliation: University of Angers
name: Sébastien Faure, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Angers
name: Aline Ramond-Roquin, Professor
role: STUDY_DIRECTOR
References: