Last updated: 01/03/2019 06:11:00
A study to estimate the occurrence of rotavirus gastroenteritis in children < 5 years of age, in Bulgaria and Latvia
GSK study ID
116621
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: At the time of enrollment of each subject (Day 0).
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.
Timeframe: 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.
Timeframe: At the time of enrollment of each subject (Day 0).
Number of hospitalisations for RV GE and AGE, reported at the primary care settings.
Timeframe: At the time of phone call follow-up contact (14 to 19 days after enrollment).
Interventions:
Other: Stool sample
Other: Data collection
Enrollment:
1266
Observational study model:
Cohort
Primary completion date:
2014-30-06
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
December 2012 to June 2014
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable - 5 years
Accepts healthy volunteers
No
- 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.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
Child in care.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2014-30-06
Actual study completion date
2014-30-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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