A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rotavirus Gastroenteritis |
Other: Stool sample Other: Data collection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- 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). ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1560 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Other: Data collection
Log books
|
|
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.
|
Other: Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Other: Data collection
Log books
|
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.
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Child in care.
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
| Bulgaria | |
| GSK Investigational Site | Not yet recruiting |
| Burgas, Bulgaria, 8000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Burgas, Bulgaria, 8018 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Dobrich, Bulgaria, 9300 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Pazardzik, Bulgaria, 4400 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Pleven, Bulgaria, 5800 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Plovdiv, Bulgaria, 4000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Ruse, Bulgaria, 7000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Sofia, Bulgaria, 1528 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Sofia, Bulgaria, 1505 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Sofia, Bulgaria, 1606 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Sofia, Bulgaria, 1517 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Stara Zagora, Bulgaria, 6000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Varna, Bulgaria, 9000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Veliko Turnovo, Bulgaria, 5000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01733849 History of Changes |
| Other Study ID Numbers: | 116621 |
| Study First Received: | November 21, 2012 |
| Last Updated: | March 7, 2013 |
| Health Authority: | Bulgaria: Ministry of Health Latvia: Central Medical Ethics Committee |
Keywords provided by GlaxoSmithKline:
|
Bulgaria Primary care settings Children Latvia Acute gastroenteritis |
Additional relevant MeSH terms:
|
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013