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.
PharmaCyst'
Sponsor study identifier
interventional
145
1 country
14
Study Start
June 30, 2023
Actual (reported)Primary Completion
October 29, 2024
Actual (reported)Study Completion
January 29, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 29, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2022
Actual (reported)August 22, 2022
Actual (reported)June 30, 2023
Actual (reported)October 29, 2024
Actual (reported)January 29, 2025
Actual (reported)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
Enrollment, Day 3
The evolution of the symptoms at D10
Enrollment, Day 10
Use of a medical consultation or an emergency service
At 3 days
Use of a medical consultation or an emergency service
At 10 days
Performing a urine dipstick
Enrollment, Day 3, Day 10
Performing a urine culture
At 3 days and 10 days
Patients' satisfaction
At 10 days
Patients' care overall satisfaction
At 10 days
Pharmacists' satisfaction
through study completion, an average of 12 months
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pharmacie du Pays De Retz
Bourgneuf-en-Retz, 44580, France
Pharmacie de Brûlon
Brûlon, France
Pharmacie Degueille
Chemazé, France
Pharmacie Nicolleau-Dilé
Chemillé-Melay, 49120, France
Pharmacie des Halles
Craon, France
Pharmacie de la Place
La Ferté-Bernard, France
Pharmacie de la Pointe
Le Mans, France
Sébastien Faure, Professor
Angers University
Aline Ramond-Roquin, Professor
Angers University
145 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2022
First Posted
August 22, 2022
Study Start
June 30, 2023
Actual (reported)Contact the study team to confirm eligibility.
Pharmacie du Centre
Le May-sur-Èvre, France
Pharmacie du Louet
Mûrs-Erigné, France
Pharmacie des Arcades
Nozay, France
Pharmacie Deroche
Roézé-sur-Sarthe, France
Pharmacie Llacuna
Sainte-Anne-sur-Brivet, France
Pharmacie du Chemin Vert
Saumur, France
Pharmacie de la Source
Sougé-le-Ganelon, France
Primary Completion
October 29, 2024
Actual (reported)Study Completion
January 29, 2025
Actual (reported)Last Updated
March 13, 2026
Record last verified: 2026-03
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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