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Rotavirus Gastroenteritis Burden and Impact Study in India

A multicentric study to determine disease burden, impact and causative rotavirus strain in Rota Virus Gastro Enteritis (RVGE) among children less then 5 years with acute gastroenteritis attending outpatient departments of private urban pediatric clinics in India.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/02/002402
Enrollment
500
Registered
2012-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Infants or children less than 5 years suffering from acute gastroenteritis Health Condition 2: A09- Infectious gastroenteritis and colitis, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Merck Sharp and Dohme
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Child with age less then 5 years (less then 60 Months) 2. Suffering from acute gastroenteritis and attending outpatient clinic (Acute Gastroenteritis: three or more loose or watery stools in a 24-hour period and / or one or more episodes of forceful vomiting). These symptoms should have occurred within the previous 72 hours) 3. Parents willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Currently enrolled in another clinical trial 2. History of receipt of rotavirus vaccine / History of rotavirus infection in past 3. Any condition that in the opinion of investigator might interfere with evaluation of study objectives. 4. Parent / guardian unable to give consent and the required information

Design outcomes

Primary

MeasureTime frame
Proportion of rotavirus gastroenteritis among children with acute gastroenteritis attending private urban outpatient clinics in IndiaTimepoint: Enrolled infants/children would be followed up for 14 days after enrollmentgastroenteritis attending private urban outpatient clinics in India

Secondary

MeasureTime frame
1. percent distribution of rotavirus serotypes among rotavirus antigen-positive diarrheal stool samples. 2. Clinical presentation and severity of acute gastroenteritis 3. Impact of rotavirus and non rotavirus gastroenteritis on parents and family 4. Expenses incurred towards management of gastroenteritisTimepoint: Enrolled infants/children would be followed up for 14 days after enrollment

Countries

India

Contacts

Public ContactDr Viraj Salgoankar

MSD Pharmaceuticals Private Limited

viraj.salgaonkar@merck.com022-6789-8888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026