Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile

The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from Valparaiso and another from Santiago.

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Key information

Conditions

Acute Diarrheal Disease Diarrhea Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Reoviridae Infections Rotavirus Infection Rotavirus Infections Signs and Symptoms Signs and Symptoms, Digestive Virus Diseases

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Dr Sotero del Rio, Santiago, Santiago Metropolitan, Chile

About this study

Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006. Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed consent is signed by parents. A fresh stool sample will be collected to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea, estimated numbers of rotavirus visits and hospitalizations will be calculated for each site. Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per center. Differences in proportion will be compared by chi square and Fischer's exact test when appropriate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with acute diarrhea
Children younger than 5 years

Exclusion criteria

Illiterate parents
Chronic gastrointestinal disease

Treatment and study plan

Primary outcomes

Proportion of rotavirus VP7 and VP4 genotypes

Time frame: two years

Secondary outcomes

Proportion of rotavirus positive episodes

Time frame: two years

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

Two Year (2009-2010) Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years of Age Requiring Emergency Room and Hospital Admission in Two Large Cities in Chile.

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: May 8, 2009
Registry last updated: May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed