跳至主要内容
临床试验/CTRI/2021/10/037230
CTRI/2021/10/037230已完成不适用

Hybrid surveillance for incidence of severe enteric fever in India

Christian Medical College2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年1月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
2
主要终点
Annual incidence of severe typhoid and paratyphoid fever in Vellore and Chandigarh cities

研究概览

简要总结

Under the Surveillance for enteric fever in India project done between 2017-20, urban areas of Vellore and Chandigarh were found to have a high burden of typhoid fever. While the incidence of typhoid was estimated as 12 per 1000 person-years (PY) in Vellore using a cohort-based approach, Chandigarh noted comparable estimates of about 10 cases per 1000 PY.Since the incidence of typhoid fever varies considerably over time and across settings, continued surveillance is necessary to establish the burden. Cohort studies, while offering good approaches to uncover ongoing transmission, are not optimal for establishing the severity of disease as the active surveillance results in early treatment, and thus bias to milder disease. Hybrid surveillance is an alternative approach that estimates the incidence of more severe enteric fever by combining hospital-based surveillance with healthcare utilization by the community and are significantly less resource-intensive. Using this approach, we will prospectively undertake blood culture surveillance for febrile admissions at hospitals that account for at least 60% of all febrile admissions in the reference population. Health care utilization pattern of the study population for fever-related hospitalizations during the study period will be captured using bi-annual healthcare utilization surveys (HCUS) as Covid-19 may influence healthcare utilization over time.

We will estimate the crude incidence of blood-culture-confirmed enteric fever by dividing the number of cases of enteric fever identified in the population at risk. These crude incidence estimates will be adjusted for healthcare utilization patterns observed in the bi-annual HCUS, the proportion of febrile admissions that received blood culture and the diagnostic accuracy blood culture (sensitivity), to arrive at the adjusted incidence of enteric fever. In addition, we will characterize the severity of enteric fever presenting at these facilities and estimate the proportion of enteric fevers that present to healthcare facilities but are managed as ambulatory patients

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting to study hospitals with a history of fever
  • Patients residing in the study area.

排除标准

  • who do not consent to the study
  • Diagnosed with malignancies.

结局指标

主要结局

Annual incidence of severe typhoid and paratyphoid fever in Vellore and Chandigarh cities

时间窗: at 2 years from study initiation

次要结局

  • To describe clinical presentation and course of illness in patients with culture confirmed enteric fever(At 2 years after initiation of the study)

研究者

申办方类型
Private medical college

研究点 (2)

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