Clinical trial NCT00895492: Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Diarrheal Disease
Rotavirus Infection
Keywords: diarrhea
rotavirus
genotype
VP4
VP7
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-05-08
Enrollment: 967
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children younger than 5 years of age with acute diarrhea or related diagnosis requiring emergency room and hospital admission in two large cities in Chile

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children with acute diarrhea
* Children younger than 5 years

Exclusion Criteria:

* Illiterate parents
* Chronic gastrointestinal disease

Primary outcomes:
measure: Proportion of rotavirus VP7 and VP4 genotypes
timeFrame: two years
Secondary outcomes:
measure: Proportion of rotavirus positive episodes
timeFrame: two years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Dr Sotero del Rio
state: Metropolitana
city: Valparaiso
country: Chile
facility: Hospital Van Buren
Study officials:
affiliation: Microbiology and Micology Program, Faculty of Medicine, University of Chile
name: Miguel L O'Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Ryan M, Diaz J, Mamani N, Navarrete M, Vallebuono C. Impact of rotavirus infections on outpatient clinic visits in chile. Pediatr Infect Dis J. 2007 Jan;26(1):41-5. doi: 10.1097/01.inf.0000247104.01291.71.
citation: O'Ryan M, Perez-Schael I, Mamani N, Pena A, Salinas B, Gonzalez G, Gonzalez F, Matson DO, Gomez J. Rotavirus-associated medical visits and hospitalizations in South America: a prospective study at three large sentinel hospitals. Pediatr Infect Dis J. 2001 Jul;20(7):685-93. doi: 10.1097/00006454-200107000-00009.