Burden of Brucella Among Children children presenting with fever for more than 7 days: A comparative cross-sectional study from a tertiary care center in northern India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Primary outcome:
研究概览
简要总结
Brucella is a zoonotic disease transmitted to humans through infected animals. It has considerable public health implications, especially in regions with inadequate food safety measures, hygiene standards, and veterinary care.1 It is endemic in areas such as the Mediterranean, the Middle East, Central and South America, and India. Due to its non-specific signs and symptoms, the disease often gets neglected.1 From the initial site of infection, the organisms spread via lymphatic vessels, infecting the local lymph glands. This leads to organisms spilling over into the bloodstream, resulting in bacteraemia, which disseminates throughout the body to involve various organs. The primary mode of disease acquisition among children is through contact with animals, exposure to the urine and feces of animals, and consumption of raw or unpasteurized milk or milk products. Considering the varied signs and symptoms, clinical diagnosis of childhood brucellosis is very difficult. Often, incorrect diagnoses occur, and sometimes it may not be possible to diagnose a disease due to a lack of testing facilities. The study aims to produce data that helps determine the prevalence of brucellosis among children and highlights the importance of considering it in differential diagnoses.2
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA FOR GROUP 1: Children aged 1 to 12 years presenting with any of the following symptoms:
- •Fever lasting more than 7 days without a known cause.
- •Joint pain (intermittent or migratory pain in large or small joints, or both, with or without limitation of movement).
- •Acute meningoencephalitis (presents with altered sensorium for more than 24 hours and at least one of the following features: fever, seizures, or focal neurological deficit, with cerebrospinal fluid showing more than 5 cells, glucose less than 2/3 of normal, and protein more than 45 mg/dl).
- •Deep-seated abscess, such as liver abscess or splenic abscess (USG of the whole abdomen proven).
- •Fever with hepatomegaly, splenomegaly, or both.
- •INCLUSION CRITERIA FOR GROUP 2: Children aged 1-12 years presenting with: • Minor ailments.
排除标准
- •EXCLUSION CRITERIA FOR GROUP 1:
- •Tested positive for any known cause.
结局指标
主要结局
Primary outcome:
时间窗: Primary outcome: | • Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with | fever or joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or | hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days.
Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with
时间窗: Primary outcome: | • Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with | fever or joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or | hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days.
fever +/- joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or
时间窗: Primary outcome: | • Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with | fever or joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or | hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days.
hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days.
时间窗: Primary outcome: | • Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with | fever or joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or | hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days.
次要结局
- Secondary Outcome(Proportion of children positive for IgM & IgG antibodies against brucellosis with or without brucella-like symptoms.)
研究者
Dr Anuradha Gupta
Maulana Azad Medical College