Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist management | Other | When a patient comes to the pharmacy with signs of urinary burning, the following will follow:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Enrollment, Day 10 |
| Use of a medical consultation or an emergency service |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' satisfaction | Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 27. A higher score mean good outcome | At 10 days |
| Patients' care overall satisfaction | Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 10. A higher score mean good outcome |
Inclusion Criteria:
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.
Exclusion Criteria:
Gender identity
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sébastien Faure, Professor | Angers University | Principal Investigator |
| Aline Ramond-Roquin, Professor | Angers University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacie du Pays De Retz | Bourgneuf-en-Retz | 44580 | France | |||
| Pharmacie de Brûlon |
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.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of consultations provided |
| At 3 days |
| Use of a medical consultation or an emergency service | Nature of consultations provided | At 10 days |
| Performing a urine dipstick | Number of urine dipstick performed | Enrollment, Day 3, Day 10 |
| Performing a urine culture | Number of urine culture performed | At 3 days and 10 days |
| Taking medication to relieve the symptoms of the infection | Number of medication used | Enrollment, |
| Taking medication to relieve the symptoms of the infection | Nature of medication used | Day 3, |
| Taking medication to relieve the symptoms of the infection | Nature of medication used | Day 10 |
| Occurrence of an adverse event at D3 and D10 | Number of adverse events | At 10 days |
| Occurrence of an adverse event at D3 and D10 | Nature of adverse events | At 3 days |
| Recurrence of a urinary tract infection within 3 months (M3) | Number of cystitis encountered | At 3 months |
| At 10 days |
| Pharmacists' satisfaction | Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 51. A higher score mean good outcome | through study completion, an average of 12 months |
| Pharmacists' experience | We will conduct semi-structured interviews with investigator pharmacyst who want's it We will explore Pharmacists' experience on the clinical research participation, including its Strengths, Weaknesses, Opportunities, and Threats. | through study completion, an average of 12 months |
| Overall satisfaction of patients | Overall satisfaction level of patients with the care provided in pharmacies. The minimum value is 0 and the maximun value is 10. A higher score mean good outcome | At 10 days |
| 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 |
| 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 |