Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 145
- 试验地点
- 15
- 主要终点
- The evolution of the symptoms at D3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and <65 years
- •Patient with less than 3 days of simple urinary tract infection symptoms:
- •Burning, pain on urination
- •Pollakiuria
- •Urinary urgency
- •Patient affiliated or beneficiary of a social insurance
- •Patient having signed an informed consent.
排除标准
- •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.
研究组 & 干预措施
Management with the protocol
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.
干预措施: Pharmacist management (Other)
Standard care
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.
结局指标
主要结局
The evolution of the symptoms at D3
时间窗: 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
次要结局
- Use of a medical consultation or an emergency service(At 10 days)
- Performing a urine culture(At 3 days and 10 days)
- Taking medication to relieve the symptoms of the infection(Day 10)
- Occurrence of an adverse event at D3 and D10(At 3 days)
- The evolution of the symptoms at D10(Enrollment, Day 10)
- Performing a urine dipstick(Enrollment, Day 3, Day 10)
- Recurrence of a urinary tract infection within 3 months (M3)(At 3 months)
- Use of a medical consultation or an emergency service(At 3 days)
- Taking medication to relieve the symptoms of the infection(Enrollment,)
- Taking medication to relieve the symptoms of the infection(Day 3,)
- Occurrence of an adverse event at D3 and D10(At 10 days)