Burden of Respiratory Viruses in India.

NCT07403019 | Not Yet Recruiting DMC

• 1 other identifier: MAHAN RSV 2025 1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  48 months

Study Arms (1)

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.

Diagnostic Test: Nasopharyngeal swab for viral analysis

Interventions

Nasopharyngeal swab for viral analysis DIAGNOSTIC_TEST

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

Cohort of 30 villages and 15 hospitals will be included.

Eligibility Criteria

• Age: 1 Minute - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study is based on a poor rural population of Melghat, Amaravati district of Maharashtra in India, where all of the participants are of Indian origin/descent. Since India is the single most important country contributing to the burden of morbidity and mortality of respiratory illness globally, and most of this occurs in parts of rural India where infant mortality and adult mortality still remains high, this population is the exact population where studies on the viral epidemiology and burden need to be conducted. Hence this population though not diverse, is a highly relevant population whether burden of disease occurs, but is really unstudied till our preceding study referenced in the text.

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.

Sponsors & Collaborators

• MAHAN Trust: lead

Study Sites (1)

Mahatma Gandhi Tribal Hospital Karmgram Utavali Dharni Amaravati

Amravati, Maharashtra, 444 702, India

Location

Related Publications (5)

• Li Y, Wang X, Blau DM, Caballero MT, Feikin DR, Gill CJ, Madhi SA, Omer SB, Simoes EAF, Campbell H, Pariente AB, Bardach D, Bassat Q, Casalegno JS, Chakhunashvili G, Crawford N, Danilenko D, Do LAH, Echavarria M, Gentile A, Gordon A, Heikkinen T, Huang QS, Jullien S, Krishnan A, Lopez EL, Markic J, Mira-Iglesias A, Moore HC, Moyes J, Mwananyanda L, Nokes DJ, Noordeen F, Obodai E, Palani N, Romero C, Salimi V, Satav A, Seo E, Shchomak Z, Singleton R, Stolyarov K, Stoszek SK, von Gottberg A, Wurzel D, Yoshida LM, Yung CF, Zar HJ; Respiratory Virus Global Epidemiology Network; Nair H; RESCEU investigators. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May 28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19.

  PMID: 35598608 BACKGROUND

• Simoes EAF, Dani V, Potdar V, Crow R, Satav S, Chadha MS, Hessong D, Carosone-Link P, Palaskar S, Satav A. Mortality From Respiratory Syncytial Virus in Children Under 2 Years of Age: A Prospective Community Cohort Study in Rural Maharashtra, India. Clin Infect Dis. 2021 Sep 2;73(Suppl_3):S193-S202. doi: 10.1093/cid/ciab481.

  PMID: 34472578 BACKGROUND

• Madhi SA, Polack FP, Piedra PA, Munoz FM, Trenholme AA, Simoes EAF, Swamy GK, Agrawal S, Ahmed K, August A, Baqui AH, Calvert A, Chen J, Cho I, Cotton MF, Cutland CL, Englund JA, Fix A, Gonik B, Hammitt L, Heath PT, de Jesus JN, Jones CE, Khalil A, Kimberlin DW, Libster R, Llapur CJ, Lucero M, Perez Marc G, Marshall HS, Masenya MS, Martinon-Torres F, Meece JK, Nolan TM, Osman A, Perrett KP, Plested JS, Richmond PC, Snape MD, Shakib JH, Shinde V, Stoney T, Thomas DN, Tita AT, Varner MW, Vatish M, Vrbicky K, Wen J, Zaman K, Zar HJ, Glenn GM, Fries LF; Prepare Study Group. Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants. N Engl J Med. 2020 Jul 30;383(5):426-439. doi: 10.1056/NEJMoa1908380.

  PMID: 32726529 BACKGROUND

• Simoes EA, Mutyara K, Soh S, Agustian D, Hibberd ML, Kartasasmita CB. The epidemiology of respiratory syncytial virus lower respiratory tract infections in children less than 5 years of age in Indonesia. Pediatr Infect Dis J. 2011 Sep;30(9):778-84. doi: 10.1097/INF.0b013e318218ab9e.

  PMID: 21487330 BACKGROUND

• Satav A, Crow R, Potdar V, Dani V, Satav S, Chadha M, Hessong D, Carosone-Link P, Palaskar S, Simoes EAF. The Burden of Respiratory Syncytial Virus in Children Under 2 Years of Age in a Rural Community in Maharashtra, India. Clin Infect Dis. 2021 Sep 2;73(Suppl_3):S238-S247. doi: 10.1093/cid/ciab508.

  PMID: 34472575 BACKGROUND

Related Links

• 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

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab collection

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ashish R Satav, MBBS. MD

  MAHAN Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish R Satav, MBBS. MD

CONTACT

+919423118877; drashish@mahantrust.org

Vibhawari Dani, MBBS. MD

CONTACT

+91 98222 27317; drvsdani@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)