Incidence and Epidemiological Characterization of Respiratory Syncytial Virus: Molecular and Clinical Insights from Coastal Karnataka.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- This study will determine the prevalence and burden of RSV across all age groups, identify circulating RSV-A and RSV-B strains through partial genome sequencing, assess the correlation between RSV viral load and clinical outcomes using quantitative PCR, contribute to molecular surveillance, and support development of monoclonal antibodies targeting the RSV Fusion (F) protein for diagnostic and therapeutic applications.
研究概览
简要总结
Respiratory Syncytial virus (RSV) is one of the major causes of Acute Lower Respiratory Tract Infection (ALRTI) in infants and children’s (more severe in <1 year age), elderly adults, pregnant women and people with immune-compromised state. However, recent reports highlight that adult population (18-65 years age) also showing severe cases of lower respiratory tract infection due to RSV infection. Despite the significant impact, data on the age-stratified burden of Respiratory Syncytial Virus (RSV) and its molecular epidemiology remain limited, especially in diverse populations. This project seeks to explore the age-related burden of respiratory syncytial virus (RSV) and its molecular characteristics to better understand the factors for disease severity. By assessing the distribution of RSV infections across age groups, the study aims to quantify its impact in terms of incidence, hospitalization rates, and clinical outcomes. This will shed light on how RSV affects individuals differently based on age, ranging from infants to elderly adults, including previously healthy individuals who are now increasingly being reported with severe RSV-associated illnesses. The molecular characteristics of RSV will be studied to identify circulating genotypes and their evolutionary patterns. By using genomic sequencing, it will help us reveal how genetic variations influence disease outcomes, including whether specific genotypes are linked to severe manifestations like acute respiratory distress or complications requiring intensive care. The study outcomes are expected to inform future public health strategies, improve patient management, and support the global effort to combat RSV-related morbidity and mortality.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Only symptomatic individuals with Acute respiratory infection (ARI)/ Severe Acute respiratory infection (SARI)/ Lower respiratory tract Infection (LRTI) from both inpatients and outpatients are considered.
- •Along with the routine samples that come to the virology department for testing under the same case definition Parents/guardians/attending physicians must provide informed consent for infants/children participants and for adult participants; they themselves must provide informed consent or their guardians/attending physicians must provide consent on behalf of them to participate in this study.
排除标准
- •Individuals with a confirmed clinical diagnosis who do not fulfill the specified case definition.
- •Individuals who have not provided consent to participate in the study.
结局指标
主要结局
This study will determine the prevalence and burden of RSV across all age groups, identify circulating RSV-A and RSV-B strains through partial genome sequencing, assess the correlation between RSV viral load and clinical outcomes using quantitative PCR, contribute to molecular surveillance, and support development of monoclonal antibodies targeting the RSV Fusion (F) protein for diagnostic and therapeutic applications.
时间窗: 24 Months
次要结局
- This study will help us determine the prevalence, distribution, and burden of RSV infections(across all age groups, including vulnerable populations, providing key epidemiological data to)
研究者
Asmita B
Manipal Institute of Virology