A Prospective Cohort Study To Compare The Burden Of Medically Attended and Community RSV, hMPV, SARS-CoV-2 and Influenza LRTI In Infants And Children Under 5 Years Of Age and Adults (16-60 Years) In Rural India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- To determine the population-based epidemiology of respiratory syncytial virus (RSV) lower respiratory tract illness (LRTI) in infants and children less than 5 years of age and adults, elderly people in rural India.
研究概览
简要总结
Trial Title: A Prospective Cohort Study To Compare The Burden Of Medically Attended and Community LRTI In Infants And Children Under 5 Years Of Age and adults (16-60 years) In India
Primary Objectives:
- To determine the population-based epidemiology, clinical features, and mortality of respiratory syncytial virus (RSV) lower respiratory tract illness (LRTI) in infants, children under 5, and adults (16-60 years) in rural India.
- To calculate the incidence of RSV LRTI classifications (non-severe, severe, very severe, hospitalization, and mortality) per 1,000 child/adult years of observation.
Secondary Objectives:
• To determine the population-based epidemiology of human metapneumovirus (hMPV), SARS-CoV-2, and influenza LRTI in the same cohort.
Study Design & Methodology:
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Type: Active surveillance, prospective longitudinal cohort study.
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Setting: 30 villages in the Melghat region of Maharashtra, India, characterized by high infant and adult mortality rates.
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Participants: All children under 5 years of age and adults aged 16-60 years residing in the study villages, including all newborns entering the cohort during the study period.
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Procedures: * Community Surveillance: Trained Village Health Workers (VHWs) will conduct weekly home visits to monitor respiratory health and identify potential LRTI cases.
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Clinical Assessment: Supervisors will verify reported LRTI cases within 24 hours using standardized WHO classifications (non-severe, severe, and very severe pneumonia).
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Medical Facility Monitoring: Hospital-based counselors will monitor all LRTI-related outpatient visits and hospitalizations from the study villages.
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Sample Collection: Nasopharyngeal (NP) swabs will be collected from all identified LRTI cases (community and facility-based) and from any participant who dies within 15 days of an LRTI diagnosis.
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Laboratory Testing: 2,000 samples will undergo real-time PCR screening and subtyping for RSV, hMPV, SARS-CoV-2, and influenza at the National Institute of Virology, Pune.
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Mortality Investigation: For all participant deaths, a standardized verbal autopsy will be conducted to determine if LRTI was the cause of death.
Statistical Plan:
- Incidence rates and 95% confidence intervals will be calculated and severity category.
- Results will be stratified by age, sex, and socioeconomic status
- Multivariate analysis will be used Study Duration: 48 months total, including 36 months of active surveillance
详细描述
Study Title:
A Prospective Cohort Study To Compare The Burden Of Medically Attended and Community RSV, hMPV, SARS-CoV-2 and influenza LRTI In Infants And Children Under 5 Years Of Age and adults (16-60 years) In Rural India
Institution Name MAHAN Trust
Investigator Contact Information:
Dr. Ashish Satav Mahatma Gandhi Tribal Hospital, Karmgram, Utavali. Tahsil Dharni, District: Amaravati, Maharashtra. India pin: 444702 Phone : +919423118877 Email: drashish@mahantrust.org
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children (0-5 years) and adults (16-60 years) from 30 villlages and 15 hospitals will be included in the study who are sufffering from pneumonia or who died. Informed written consent from parents, patients and spouse or children in necessary
排除标准
- •All other healthy people from the study area will be excluded or who donot give informed written consent will be excluded.
研究组 & 干预措施
Cohort of 30 villages and 15 hospitals will be included.
We propose an active surveillance observational study in Melghat of a cohort of all newborns, infants and children under 5 years, and adults in age group of 16-60 years, for 36 months, of LRTI detected at home, primary health centers or hospitals in the catchment area of 30 villages under surveillance. The age range for the adult participants is 16-60 years.
干预措施: Nasopharyngeal swab for viral analysis (Diagnostic Test)
结局指标
主要结局
To determine the population-based epidemiology of respiratory syncytial virus (RSV) lower respiratory tract illness (LRTI) in infants and children less than 5 years of age and adults, elderly people in rural India.
时间窗: 48 months
1. To prospectively determine the clinical features of RSV lower respiratory tract illness in a cohort of infants and children under 5 years and adults, elderly people in 30 villages, over 3 years, and all newborns entering the cohort during the 3 years of the study. 2. To prospectively determine the mortality from RSV lower respiratory tract illness in a cohort of infants and children under 5 years and adults, elderly people in 30 villages, over 3 years, and all newborns entering the cohort during the 3 years of the study. 3. To determine the incidence (per 1000 child years and adults, elderly people of observation) of the following classifications of RSV LRTI, using the WHO classification of disease: non-severe pneumonia, severe pneumonia, very severe pneumonia, RSV hospitalization, RSV mortality. 4. To evaluate the RSV subgroup specific (RSV A and RSV B) burden of illness 5. To compare severity and incidence based on subgrouping.
次要结局
未报告次要终点