跳至主要内容
临床试验/CTRI/2022/06/043246
CTRI/2022/06/043246尚未招募不适用

Evaluation of a clinical score to differentiate between bacterial and non bacterial etiology in the first 4 days of a febrile illness in children

Indian Academy of Pediatrics Mumbai IAPM23 个研究点 分布在 1 个国家目标入组 2,115 人开始时间: 2022年6月30日最近更新:

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)

研究者

发起方
Indian Academy of Pediatrics Mumbai IAPM
申办方类型
Other [Independent Association]

研究点 (23)

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