Burden of Respiratory Viruses in India.

Condition(s) studied

Investigational drug(s) / intervention(s)

Nasopharyngeal swab for viral analysis: Active surveillance for LRTI cases in the community will be performed through weekly home visits by village health workers (VHWs) The VHWs are local women living in and accepted by the community. They have been trained using standard WHO materials, translated into Hindi. A nasopharyngeal swab will be obtained from children and adults (16-60 years) with non-severe, severe or very severe LRTI and those who die in 30 villages and 15 hospitals. A counselor is posted at every hospital and PHC who will capture every hospitalization of children under 5 and adults from the 30 villages, will identify any children from the 30 villages who visit the OPD with an LRTI and collect a swab from them. Children/adult with any lower respiratory illness will have a swab collected at admission and from any child/adult who dies. Samples (2000) will be tested for a panel of respiratory viruses first with a screening PCR(RSV, hMPV, SARS CoV 2 and Influenza) followed by subtyping when positive (RSV A

Study summary

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:

* Type: Active surveillance, prospective longitudinal cohort study.
* Setting: 30 villages in the Melghat region of Maharashtra, India, characterized by high infant and adult mortality rates.
* 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.
* Procedures: \* Community Surveillance: Trained Village Health Workers (VHWs) will conduct weekly home visits to monitor respiratory health and identify potential LRTI cases.

* Clinical Assessment: Supervisors will verify reported LRTI cases within 24 hours using standardized WHO classifications (non-severe, severe, and very severe pneumonia).
* Medical Facility Monitoring: Hospital-based counselors will monitor all LRTI-related outpatient visits and hospitalizations from the study villages.
* 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.
* 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.
* 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

Eligibility

Primary outcome measure(s)

• 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. — 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.

Trial sites (1)

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