A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
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| ClinicalTrials.gov Identifier: NCT01733849 |
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Recruitment Status :
Completed
First Posted : November 27, 2012
Last Update Posted : January 18, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Infections, Rotavirus | Other: Stool sample Other: Data collection |
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 Type : | Observational |
| Actual Enrollment : | 1266 participants |
| 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 |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Gastroenteritis
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Stool sample
Samples will be tested to determine the presence or absence of rotavirus. Other: Data collection Log books |
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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.
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Other: Stool sample
Samples will be tested to determine the presence or absence of rotavirus. Other: Data collection Log books |
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). ]
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733849
Locations
Show 57 study locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01733849 |
| Other Study ID Numbers: |
116621 |
| First Posted: | November 27, 2012 Key Record Dates |
| Last Update Posted: | January 18, 2017 |
| Last Verified: | January 2017 |
Keywords provided by GlaxoSmithKline:
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Bulgaria Primary care settings Children Latvia Acute gastroenteritis |
Additional relevant MeSH terms:
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Rotavirus Infections Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Reoviridae Infections RNA Virus Infections Virus Diseases |