Burden of Respiratory Viruses in India.

Starting soon

Conditions studied: Pneumonia

In brief

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

Key facts

Study ID

NCT07403019

Run by

MAHAN Trust

People needed

2000

Starts

2026-04-01

Expected to finish

2030-06-30

Last updated by the study team

2026-02-18

Who can join

Age: any, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• All other healthy people from the study area will be excluded or who donot give informed written consent will be excluded.

Where it is running

• Mahatma Gandhi Tribal Hospital Karmgram Utavali Dharni Amaravati — Amravati, Maharashtra, India

Full record on ClinicalTrials.gov

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