Infections, RotavirusNCT01733849
A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 57 sites in 2 countries.
Trial summary
This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age. 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?
- Stool sample and Data collection
- How many people
- 1,266 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Dec 2012to Jun 2014
- 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: Infants/children less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Who may be able to join
- Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for AGE treatment during the study period.
- A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday.
- Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject.
- Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol.
Who cannot join
- Child in care.
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
Latvia42 sites
GSK Investigational Site
Balvi, LV-4501
GSK Investigational Site
Bauska, LV-3901
GSK Investigational Site
Brocēni, LV-3851
GSK Investigational Site
Carnikava, LV-2163
GSK Investigational Site
Daugavpils, LV-5401
GSK Investigational Site
Daugavpils, LV-5410
GSK Investigational Site
Druva, LV-3862
GSK Investigational Site
Erglu Pagasts, LV-4840
GSK Investigational Site
Grobiņa, LV-3430
GSK Investigational Site
Ikšķile, LV-5052
GSK Investigational Site
Jēkabpils, LV-5201
GSK Investigational Site
Jelgava, LV-3001
GSK Investigational Site
Jelgava, LV-3002
GSK Investigational Site
Jelgava, LV-3007
GSK Investigational Site
Jelgava, LV-3008
GSK Investigational Site
Kuldīga, LV-3300
GSK Investigational Site
Liepāja, LV-3401
GSK Investigational Site
Limbaži, LV-4001
GSK Investigational Site
Līvāni, LV-5316
GSK Investigational Site
Madona, LV-4801
GSK Investigational Site
Ogre, LV-5001
GSK Investigational Site
Ozolnieki, LV-3018
GSK Investigational Site
Piņķi, LV-2107
GSK Investigational Site
Rēzekne, LV-4601
GSK Investigational Site
Rēzekne, LV-4604
GSK Investigational Site
Riga, LV-1001
GSK Investigational Site
Riga, LV-1002
GSK Investigational Site
Riga, LV-1010
GSK Investigational Site
Riga, LV-1011
GSK Investigational Site
Riga, LV-1012
GSK Investigational Site
Riga, LV-1024
GSK Investigational Site
Riga, LV-1050
GSK Investigational Site
Riga, LV-1063
GSK Investigational Site
Riga, LV-1082
GSK Investigational Site
Ropaži, LV-2135
GSK Investigational Site
Sigulda, LV-2150
GSK Investigational Site
Tukums, LV-3101
GSK Investigational Site
Valmiera, LV-4200
GSK Investigational Site
Valmiera, LV-4201
GSK Investigational Site
Vangaži, LV-2136
GSK Investigational Site
Ventspils, LV-3601
GSK Investigational Site
Ventspils, LV-3602
Bulgaria15 sites
GSK Investigational Site
Burgas, 8000
GSK Investigational Site
Burgas, 8018
GSK Investigational Site
Dobrich, 9300
GSK Investigational Site
Pazardzhik, 4400
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Plovdiv, 4000
GSK Investigational Site
Rousse, 7000
GSK Investigational Site
Sliven, 8800
GSK Investigational Site
Sofia, 1505
GSK Investigational Site
Sofia, 1517
GSK Investigational Site
Sofia, 1528
GSK Investigational Site
Sofia, 1606
GSK Investigational Site
Stara Zagora, 6000
GSK Investigational Site
Varna, 9000
GSK Investigational Site
Veliko Tarnovo, 5000
About this study
Official title: An Observational Study to Estimate the Disease Burden of Rotavirus Gastroenteritis in Infants/Children Less Than Five Years of Age in Primary Care Settings, in Bulgaria and Latvia
This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.
Read the detailed description
A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians.
Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.
- Conditions
- Infections, Rotavirus
- Being tested
- Stool sample, Data collection
- Keywords
- Bulgaria, Primary care settings, Children, Latvia, Acute gastroenteritis
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleOther
Samples will be tested to determine the presence or absence of rotavirus.
Data collectionOther
Log books
| Study group | Role | What they receive |
|---|---|---|
| Group Bulgaria | Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE. Receives: Other: Stool sample; Other: Data collection | |
| Group Latvia | Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE. Receives: Other: Stool sample; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.
Measured: At the time of enrollment of each subject (Day 0).
Secondary outcomes (3)
Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.
Measured: Day 0 - Day 14+5 (At the time of phone call follow-up contact).
Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.
Measured: At the time of enrollment of each subject (Day 0).
Number of hospitalisations for RV GE and AGE, reported at the primary care settings.
Measured: At the time of phone call follow-up contact (14 to 19 days after enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
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
- 1,266 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
- NCT01733849
- Sponsor's protocol ID
- 116621
- Status last verified
- Jan 2017
- First submitted
- 21 Nov 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
Publications
Tafalla M, Gardovska D, Gopala K, Kozlovska L. Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis. Hum Vaccin Immunother. 2019;15(6):1272-1278. doi: 10.1080/21645515.2018.1534515. Epub 2018 Oct 31.
PubMed 30335570Tiholova M, Gopala K, Berberova M, Strokova-Stoilova M, Tafalla M. Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study. Germs. 2016 Sep 1;6(3):97-105. doi: 10.11599/germs.2016.1095. eCollection 2016 Sep.
PubMed 27622162
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Estimate the Disease Burden of Rotavirus Gastroenteritis in Infants/Children Less Than Five Years of Age in Primary Care Settings, in Bulgaria and Latvia
- ClinicalTrials.gov ID
- NCT01733849
- Acronym / sponsor ID
- 116621
- Conditions
- Infections, Rotavirus
- Keywords
- Bulgaria, Primary care settings, Children, Latvia, Acute gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Nov 2012 (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.
This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.
Detailed description
A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians.
Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Bulgaria | – | Other: Stool sample, Other: Data collectionSubjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE. |
| Group Latvia | – | Other: Stool sample, Other: Data collectionSubjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants/children less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Key inclusion criteria (4 listed)
- Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for AGE treatment during the study period.
- A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday.
- Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject.
- Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol.
Key exclusion criteria (1 listed)
- Child in care.
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 |
|---|---|---|
| Stool sampleSamples will be tested to determine the presence or absence of rotavirus. | Other | Group Bulgaria, Group Latvia |
| Data collectionLog books | Other | Group Bulgaria, Group Latvia |
Primary outcome
Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.
Time frame: At the time of enrollment of each subject (Day 0).
3 secondary outcomes
Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.
Time frame: Day 0 - Day 14+5 (At the time of phone call follow-up contact).
Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.
Time frame: At the time of enrollment of each subject (Day 0).
Number of hospitalisations for RV GE and AGE, reported at the primary care settings.
Time frame: At the time of phone call follow-up contact (14 to 19 days after enrollment).
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 18 Jan 2017.
- Derived from this study: PubMed 30335570Tafalla M, Gardovska D, Gopala K, Kozlovska L. Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis. Hum Vaccin Immunother. 2019;15(6):1272-1278. doi: 10.1080/21645515.2018.1534515. Epub 2018 Oct 31.
- Derived from this study: PubMed 27622162Tiholova M, Gopala K, Berberova M, Strokova-Stoilova M, Tafalla M. Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study. Germs. 2016 Sep 1;6(3):97-105. doi: 10.11599/germs.2016.1095. eCollection 2016 Sep.
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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
57 sites in 2 countries: 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 57 sites in 2 countries.
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 4 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Latvia, Bulgaria. 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?
Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age. (time frame: At the time of enrollment of each subject (Day 0).). 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 NCT01733849, 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 18 Jan 2017.