Infections, RotavirusNCT01253967
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 8 sites in Romania.
Trial summary
The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Collection of stool samples and Health economics questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 1,234 participants
- Where
- 8 sitesRomania
- Study dates
- Feb 2008to Jan 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children < 5 years of age treated at a hospital site (subjects hospitalised with community acquired acute gastroenteritis, subjects who visited the emergency room for acute gastroenteritis or subjects with medical care associated rotavirus infection).
Who may be able to join
- A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.
- A subject, who during the study period:
- Is hospitalised for acute gastroenteritis Or
- Visits an emergency room for acute gastroenteritis Or
- Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation
Who cannot join
- Not applicable
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Romania8 sites
GSK Investigational Site
Bucharest, 021105
GSK Investigational Site
Bucharest
GSK Investigational Site
Cluj-Napoca, 400348
GSK Investigational Site
Cluj-Napoca
GSK Investigational Site
Constanța, 900708
GSK Investigational Site
Craiova
GSK Investigational Site
Sibiu
GSK Investigational Site
Timișoara
About this study
Official title: Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.
Read the detailed description
The study consist of a main study and a health economics study
Main study: The study will focus on three different groups of patients:
- Subjects who are hospitalised for acute gastroenteritis.
- Subjects who visit an emergency room for acute gastroenteritis.
- Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.
Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire
- Conditions
- Infections, Rotavirus
- Being tested
- Collection of stool samples, Health economics questionnaire
- Keywords
- Gastroenteritis, Hospital surveillance, Rotavirus gastroenteritis
- Medical subject headings
- Rotavirus Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool samplesProcedure or surgery
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Health economics questionnaireOther
For a subset of subjects, additional economic data will be gathered by completing a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects who are hospitalised for acute gastroenteritis Receives: Procedure: Collection of stool samples; Other: Health economics questionnaire | |
| Group B | Subjects who visit an emergency room for acute gastroenteritis Receives: Procedure: Collection of stool samples; Other: Health economics questionnaire | |
| Group C | Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation. Receives: Procedure: Collection of stool samples; Other: Health economics questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age
Measured: At least 12 months from study start
Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age
Measured: At least 12 months from study start
Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age
Measured: At least 12 months from study start
Secondary outcomes (10)
Age distribution of children with rotavirus gastroenteritis
Measured: At least 12 months from study start
Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age
Measured: At least 12 months from study start
Potential risk factors for rotavirus gastroenteritis
Measured: At least 12 months from study start
Rotavirus gastroenteritis associated costs
Measured: At least 12 months from study start
Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age
Measured: At least 12 months from study start
Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age
Measured: At least 12 months from study start
Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age
Measured: At least 12 months from study start
Severity of rotavirus among all children < 5 years of age
Measured: At least 12 months from study
Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age
Measured: At least 12 months from study start
Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age
Measured: At least 12 months from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 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 Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253967
- Sponsor's protocol ID
- 110436
- Status last verified
- Apr 2015
- First submitted
- 30 Nov 2010
- Last updated
- 13 Apr 2015
- Results posted
- No
Publications
Benea OE, Streinu-Cercel A, Dorobat C, Rugina S, Negrutiu L, Cupsa A, Duiculescu D, Chiriac C, Itu C, Prisacariu LJ, Iosif I. Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study. Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 Sep.
PubMed 25276665Anca IA, Furtunescu FL, Plesca D, Streinu-Cercel A, Rugina S, Holl K. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children below five years of age in Romania. Germs. 2014 Jun 2;4(2):30-40. doi: 10.11599/germs.2014.1053. eCollection 2014 Jun.
PubMed 24967217
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
- ClinicalTrials.gov ID
- NCT01253967
- Acronym / sponsor ID
- 110436
- Conditions
- Infections, Rotavirus
- Keywords
- Gastroenteritis, Hospital surveillance, Rotavirus gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Dec 2010 (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 hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.
Detailed description
The study consist of a main study and a health economics study
Main study: The study will focus on three different groups of patients:
- Subjects who are hospitalised for acute gastroenteritis.
- Subjects who visit an emergency room for acute gastroenteritis.
- Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.
Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Collection of stool samples, Other: Health economics questionnaireSubjects who are hospitalised for acute gastroenteritis |
| Group B | – | Procedure: Collection of stool samples, Other: Health economics questionnaireSubjects who visit an emergency room for acute gastroenteritis |
| Group C | – | Procedure: Collection of stool samples, Other: Health economics questionnaireSubjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children < 5 years of age treated at a hospital site (subjects hospitalised with community acquired acute gastroenteritis, subjects who visited the emergency room for acute gastroenteritis or subjects with medical care associated rotavirus infection).
Key inclusion criteria (5 listed)
- A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.
- A subject, who during the study period:
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of stool samplesStool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped. | Procedure or surgery | Group A, Group B, Group C |
| Health economics questionnaireFor a subset of subjects, additional economic data will be gathered by completing a questionnaire | Other | Group A, Group B, Group C |
Primary outcome
Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age
Time frame: At least 12 months from study start
Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age
Time frame: At least 12 months from study start
Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age
Time frame: At least 12 months from study start
10 secondary outcomes
Age distribution of children with rotavirus gastroenteritis
Time frame: At least 12 months from study start
Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age
Time frame: At least 12 months from study start
Potential risk factors for rotavirus gastroenteritis
Time frame: At least 12 months from study start
Rotavirus gastroenteritis associated costs
Time frame: At least 12 months from study start
Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age
Time frame: At least 12 months from study start
Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age
Time frame: At least 12 months from study start
Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age
Time frame: At least 12 months from study start
Severity of rotavirus among all children < 5 years of age
Time frame: At least 12 months from study
Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age
Time frame: At least 12 months from study start
Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age
Time frame: At least 12 months from study start
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 13 Apr 2015.
- Derived from this study: PubMed 25276665Benea OE, Streinu-Cercel A, Dorobat C, Rugina S, Negrutiu L, Cupsa A, Duiculescu D, Chiriac C, Itu C, Prisacariu LJ, Iosif I. Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study. Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 Sep.
- Derived from this study: PubMed 24967217Anca IA, Furtunescu FL, Plesca D, Streinu-Cercel A, Rugina S, Holl K. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children below five years of age in Romania. Germs. 2014 Jun 2;4(2):30-40. doi: 10.11599/germs.2014.1053. eCollection 2014 Jun.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 8 sites in Romania.
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 5 inclusion and 1 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Romania. 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 gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age (time frame: At least 12 months from study start). The study lists 3 primary outcomes in all. 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 NCT01253967, 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 13 Apr 2015.