跳至主要内容
临床试验/CTRI/2025/03/082030
CTRI/2025/03/082030尚未招募不适用

A study to assess the disease severity among scrub typhus and leptospirosis patients using clinical, immunological, and molecular tools

ICMR Small Extramural funding scheme1 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2025年4月7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
311
试验地点
1
主要终点
Understanding the predictors to distinguish between scrub typhus and leptospirosis based on clinical, laboratory, and immunological profile

研究概览

简要总结

Scrub typhus and leptospirosis are zoonotic acute undifferentiated febrile illnesses often associated with similar clinical manifestations and risk factors. Both illnesses can range from self-limiting to severe disease and multi-organ failure. If left untreated, scrub typhus can lead to death in 30-35% of cases, while severe leptospirosis has a case fatality rate ranging from 5-20%. The confirmatory tests for scrub typhus and leptospirosis, which are IFA and MAT, are time-consuming, expensive, require experienced laboratory personnel, and are unsuitable for early detection. Due to the cross-reactivity between these tests, there may be a significant overlap and misclassification in serological tests. The association between the host immune response and disease severity might help to better understand the pathogenesis of these infections. Determining the predictors of disease severity that can be used as a biomarker to distinguish between scrub typhus and leptospirosis might help in choosing empirical antibiotics. However, no studies have explored the cytokine profile in both infections, which could serve as a prognostic marker to improve patient management in severe conditions.

The current study aims to determine the association between disease severity and laboratory, molecular, and immune profiles in scrub typhus and leptospirosis. Additionally, the study determines the novel target gene combinations with optimal sensitivity and specificity for the early diagnosis of scrub typhus disease.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients with suspected or confirmed diagnosis of scrub typhus and leptospirosis.
  • For healthy controls, participants with no history of fever for the past month.

排除标准

  • Pregnant women, Individuals with coinfections, immunocompromised, and autoimmune disorders.

结局指标

主要结局

Understanding the predictors to distinguish between scrub typhus and leptospirosis based on clinical, laboratory, and immunological profile

时间窗: 2nd year

次要结局

  • Understanding the importance/role of corticosteroids in the management of severe(scrub typhus patients)

研究者

发起方
ICMR Small Extramural funding scheme
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Kavitha Saravu

Kasturba Medical college Manipal

研究点 (1)

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