Evaluation of a clinical score to differentiate between bacterial and non bacterial etiology in the first 4 days of a febrile illness in children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,115
- 试验地点
- 23
- 主要终点
- To evaluate a clinical score to suspect or rule out acute bacterial infection during first 3-4 days of fever by analysis of detailed history
研究概览
简要总结
There is a high prevalence of antimicrobial resistance among the bacterial isolates of blood stream infections among Indian children. Misuse of antibiotics is an important factor for accelerating the resistance mechanisms among bacteria. Presently physicians rely on their clinical skills to decide on prescribing an antibiotic and these skills vary from individual to individual. There is a clear need for a clinical scoring tool which can be conveniently utilized in the first visit of a child presenting with an acute febrile illness and which can most accurately rule out bacterial infections requiring antibiotics in the first four days of illness. For a better acceptance, this tool needs to be reliable, inexpensive, non invasive and simple for use in a resource limited setting
The data obtained regarding the characteristics of fever will be converted into a score. This will be used to put down a provisional diagnosis of bacterial infection or no bacterial infection. Bacterial infection is assigned lower points and higher points for other causes. Points are assigned as per the importance of relevance for differentiation. Inter-febrile period is the most important point of difference and hence assigned 3 points in favour of non-bacterial and 0 point for bacterial infection.
An independent observer will record the observations/data required to use the clinical tool without interfering with the patient management by the primary pediatrician. Therefore there are no indirect or direct benefit or risk to the patients during the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy children between age of 6 months and 18 years presenting with acute onset of fever of short duration without exposure to antibiotics in last two weeks.
排除标准
- •Children with following diseases acute severe acute malnutrition, known congenital defects or diseases, serious situations (Behavior change, poor urine output, respiratory distress, hemodynamic instability, purpuric rash or gangrenous skin, meningeal signs).
- •Children who have received antibiotics in the first 48 hrs since the onset of fever.
- •Post vaccination fever.
结局指标
主要结局
To evaluate a clinical score to suspect or rule out acute bacterial infection during first 3-4 days of fever by analysis of detailed history
时间窗: 14 days
次要结局
- To evaluate the proportion of children in whom use of antibiotics is not justified.(To evaluate the utility of the tool to reduce irrational use of antibiotics among children)
