Diagnostic Process in Patients With a Suspected Urinary Trcat Infection in Danish Primary Care: Impact on Appropriate Use of Antibiotics and Patient's Recovery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of patients with appropriate antibiotic treatment decisions for each diagnostic approach during the consultation.
研究概览
简要总结
Background: Inappropriate use of antibiotics is one of the main causes for the increase of antibiotic resistance strains. In Denmark general practice accounts for 90% of all prescribed antibiotics and one of the most common reasons for prescribing antibiotics is the suspicion of a urinary tract infection (UTI). The use of point-of-care test is meant to decrease the uncertainty about the bacterial origin of the symptoms; however, there is a paucity of knowledge about the validity of the different diagnostic approaches, thus impacting on the proper use of antibiotics.
Objective: To assess the diagnostic validity of different diagnostic approaches in patients with a suspected urinary tract infection and assess the impact on appropriate use of antibiotics.
Methods: 70 practices at the capital region will consecutively include 15-20 patients. The inclusion criteria of the patients comprise: a) Suspected Urinary tract infection, b) > 18 years of age, c) patient consulting during office hours. Data at patient and GP level will be gathered.
16 diagnostic approaches will be compared and proper use of antibiotics will be assessed as a two-step process. The first step is the decision made during the consultation and the second step is the decision made after the consultation. Sensitivity, specificity and predictive values will be measure for each diagnostic approach using urine culture as a gold standard. The impact on proper use of antibiotics will be assessed in a hierarchical multivariable logistic model.
详细描述
Background
The latest report from the Staten Serum Institute (SSI)1 showed that primary health care in Denmark represents 90% of all prescribed defined daily dose(DDD) of antibiotics, and that a growing consumption of antibiotics is running alongside increasing resistance to E. coli, specifically ESBL-producing E. coli (Extended Spectrum Beta Lactamase Producing E. coli) .
The main cause of E. coli infection at primary care level is a Urinary Tract Infection (UTI) which is one of the most frequent reasons for consultation in general practice in Denmark. Interestingly, there is no consensus yet about the most effective diagnostic approach to identify those patients that will benefit from antibiotic therapy.
Currently in Denmark, a wide variety of diagnostic approaches can be identified in primary care settings (i.e. only history taking, dipsticks, microscopy, culture and susceptibility testing in practice). Nonetheless, there is not conclusive evidence yet about the diagnostic validity of all these approaches and the association with appropriate prescription of antibiotics(i.e. correct decision to prescribe and correct choice of antibiotics reflecting the bacterial cause and resistance) and impact on patients' clinical and microbiological cure.
For example, some studies that only include uncomplicated UTIs have shown that symptoms alone have a very low predictive value leading to overuse of antibiotics2,3. However, Richards et al after comparing the response to antibiotics of women with symptoms of UTI and a negative dipstick test result, concluded that empirical antibiotic use guided only by symptoms was a reasonable option4.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected Urinary tract infection
- •> 18 years of age
- •Patient consulting during office hours.
排除标准
- •Patients currently taking antibiotics
- •Inability to complete a diary and send two urine samples during the time of the study
- •Patients with a urinary catheter as they have a closer follow-up between first and secondary care.
结局指标
主要结局
Percentage of patients with appropriate antibiotic treatment decisions for each diagnostic approach during the consultation.
时间窗: 8 months
We will compare appropriate use of antibiotics within the different diagnostic approaches
次要结局
- Number of days until clinical cure.(8 months)
- Number of days until microbiological cure.(8 months)
- Prevalence of resistant strains(8 months)
研究者
Gloria Cristina Cordoba
MD-MPH
University of Copenhagen
