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 recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by University of Chile.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Merck

Information provided by:

University of Chile

ClinicalTrials.gov Identifier:

NCT00895492

First received: May 6, 2009

Last updated: May 7, 2009

Last verified: May 2009

History of Changes

Purpose

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.

Condition
Acute Diarrheal Disease Rotavirus Infection

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
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.

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Rotavirus Infections

U.S. FDA Resources

Further study details as provided by University of Chile:

Primary Outcome Measures:

Proportion of rotavirus VP7 and VP4 genotypes [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of rotavirus positive episodes [ Time Frame: two years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

stool

Estimated Enrollment:	750
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2011

Groups/Cohorts
Sotero del Rio Emergency Room and Hospital based surveillance
Van Buren Emergency Room and Hospital based surveillance

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

Ages Eligible for Study:	1 Month to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

Inclusion Criteria:

Children with acute diarrhea
Children younger than 5 years

Exclusion Criteria:

Illiterate parents
Chronic gastrointestinal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895492

Contacts

Contact: Miguel O'Ryan, MD

9786145

moryan@med.uchile.cl

Locations

Chile
Hospital Dr Sotero del Rio	Recruiting
Santiago, Metropolitana, Chile
Contact: Alfredo Peña, MD 92377215 alfredop@ctcinternet.cl
Principal Investigator: Alfredo Peña, MD
Hospital Van Buren	Not yet recruiting
Valparaiso, Chile
Contact: Rodrigo Vergara, MD 5697998786 rvergara@ucv.cl
Principal Investigator: rodrigo vergara, MD

Sponsors and Collaborators

University of Chile

Merck

Investigators

Principal Investigator:

Miguel L O'Ryan, MD

Microbiology and Micology Program, Faculty of Medicine, University of Chile

More Information

Publications:

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.

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.

Responsible Party:	Miguel O'Ryan, University of Chile
ClinicalTrials.gov Identifier:	NCT00895492 History of Changes
Other Study ID Numbers:	Merck 2009
Study First Received:	May 6, 2009
Last Updated:	May 7, 2009
Health Authority:	Chile: Hospital Dr. Sotero del Río IRB

Keywords provided by University of Chile:

diarrhea
rotavirus
genotype
VP4
VP7

Additional relevant MeSH terms:

Diarrhea
Emergencies
Rotavirus Infections
Signs and Symptoms, Digestive
Signs and Symptoms

Disease Attributes
Pathologic Processes
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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