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A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01733849
First received: November 21, 2012
Last updated: January 16, 2017
Last verified: January 2017
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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 |
|---|---|
| Infections, Rotavirus | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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). ]
Secondary Outcome Measures:
- 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). ]
| Enrollment: | 1266 |
| Study Start Date: | December 2012 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (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 (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01733849
Show 57 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733849
Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01733849 History of Changes |
| Other Study ID Numbers: |
116621 |
| Study First Received: | November 21, 2012 |
| Last Updated: | January 16, 2017 |
Keywords provided by GlaxoSmithKline:
|
Bulgaria Primary care settings Children Latvia Acute gastroenteritis |
Additional relevant MeSH terms:
|
Gastroenteritis Rotavirus Infections Gastrointestinal Diseases Digestive System Diseases |
Reoviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on June 23, 2017