Acute Diarrheal DiseaseNCT00895492
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
An observational study of Acute Diarrheal Disease and Rotavirus Infection, run by University of Chile at 2 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Acute Diarrheal Disease, Rotavirus Infection
- How many people
- 967 participants
- Where
- 2 sitesChile
- Study dates
- May 2009to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Children with acute diarrhea
- Children younger than 5 years
Who cannot join
- Illiterate parents
- Chronic gastrointestinal disease
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Dr Sotero del Rio
Santiago, Santiago Metropolitan
Hospital Van Buren
Valparaíso, Valparaiso
About this study
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.
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.
Read the 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.
- Conditions
- Acute Diarrheal Disease, Rotavirus Infection
- Keywords
- diarrhea, rotavirus, genotype, VP4, VP7
- Medical subject headings
- Rotavirus Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sotero del Rio | Emergency Room and Hospital based surveillance | |
| Van Buren | Emergency Room and Hospital based surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of rotavirus VP7 and VP4 genotypes
Measured: two years
Secondary outcomes (1)
Proportion of rotavirus positive episodes
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Diarrheal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Miguel O'Ryan Gallardo, University of Chile
- Investigators
- Miguel L O'Ryan, MD, Principal investigator, Microbiology and Micology Program, Faculty of Medicine, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895492
- Sponsor's protocol ID
- Merck 2009
- Status last verified
- Apr 2014
- First submitted
- 6 May 2009
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17195704O'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.
PubMed 11465841
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00895492
- Acronym / sponsor ID
- Merck 2009
- Conditions
- Acute Diarrheal Disease, Rotavirus Infection
- Keywords
- diarrhea, rotavirus, genotype, VP4, VP7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotero del Rio | – | –Emergency Room and Hospital based surveillance |
| Van Buren | – | –Emergency Room and Hospital based surveillance |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Children with acute diarrhea
- Children younger than 5 years
Key exclusion criteria (2 listed)
- Illiterate parents
- Chronic gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of rotavirus VP7 and VP4 genotypes
Time frame: two years
1 secondary outcome
Proportion of rotavirus positive episodes
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Background: PubMed 17195704O'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.
- Background: PubMed 11465841O'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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel L O'Ryan, MD principal investigator
Microbiology and Micology Program, Faculty of Medicine, University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diarrheal Disease and Rotavirus Infection, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of rotavirus VP7 and VP4 genotypes (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00895492, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.