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

Rotavirus Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895492
• Other study ID #: Merck 2009
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: April 30, 2014
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2014
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Hospital Dr. Sotero del Río IRB
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 967
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

• Children with acute diarrhea

• Children younger than 5 years

Exclusion Criteria:

• Illiterate parents

• Chronic gastrointestinal disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Diarrheal Disease
• Diarrhea
• Rotavirus Infection
• Rotavirus Infections

Locations

Country	Name	City	State
Chile	Hospital Dr Sotero del Rio	Santiago	Metropolitana
Chile	Hospital Van Buren	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Chile, 

References & Publications (2)

O'Ryan M, Díaz 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. — View Citation

O'Ryan M, Pérez-Schael I, Mamani N, Peña A, Salinas B, González G, González F, Matson DO, Gómez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of rotavirus VP7 and VP4 genotypes		two years	No
Secondary	Proportion of rotavirus positive episodes		two years	No