Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Rate of broad-spectrum antibiotic dispensing
研究概览
简要总结
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics.
The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation).
The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women ≥18 years of age,
- •affiliated with the CPAM of Loire Atlantique (44) or Maine et Loire (49),
- •with a urine culture: i) analyzed by LabOuest, ii) positive for E. coli, and iii) associated with a prescription for antibiotics by a general practitioner in the period 7 days before and 14 days after the antibiotic susceptibility testing.
- •General practitioners :
- •practicing in primary care Loire Atlantique (44) and/or Maine et Loire (49),
- •having been consulted by at least 100 different patients in the 12 months prior to baseline,
- •having received at least one urine culture result for a woman ≥18 years of age analyzed by LabOuest over the 12 months prior to baseline.
排除标准
- •hospitalized in the period 7 days before and 14 days after antibiotic susceptibility testing (data on antibiotics dispensed in healthcare institutions are not accessible via DCIR data),
- •with reimbursements for antibiotics prescribed by physicians in different practices over the period 7 days before and 14 days after antibiotic susceptibility testing.
- •General practitioners :
- •with a special practice (acupuncture, allergology, angiology).
- •not receiving any urine culture results analyzed by a laboratory of the LabOuest network in the year following the intervention
结局指标
主要结局
Rate of broad-spectrum antibiotic dispensing
时间窗: 5 days
The primary endpoint will be the rate of broad-spectrum antibiotic dispensing, defined as the number of urine cultures associated with a prescription of broad-spectrum antibiotics (Amoxicillin/clavulanic acid, fluoroquinolone, third-generation cephalosporin) prescribed by GPs in the same practice over a period from 3 days before to 5 days after report of the antibiotic susceptibility testing, relative to the total number of urine cultures. This period of interest corresponds to the period of empirical antibiotic therapy (=within 3 days before report of the antibiotic susceptibility testing), and the period of directed antibiotic therapy (=within 5 days after report of the antibiotic susceptibility testing). A sensitivity analysis of the primary endpoint will be carried out by varying the time window for broad-spectrum antibiotic dispensing around the date of the antibiotic susceptibility testing result, up to a maximum of 7 days before and 14 days after.
次要结局
- E.coli antimicrobial susceptibility profiles(5 days)
- Patient characteristics (age, diabetes, pregnancy, nursing home)(5 days)
- Rate of broad-spectrum antibiotic dispensing as a function of the number of selective antibiotic susceptibility testings received per practice, as a continuous variable ("dose-effect") and ordinal variable ("threshold-effect")(5 days)
- GP characteristics: demographics (age, gender), practice patterns (type of practice commune based on INSEE urban area zoning), number of encounters/year, and number of patients declared(5 days)
- Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)(5 days)
- "Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy(5 days)