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
Study complete
Study complete
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:
Enrollment:
1266
Primary completion date:
2014-30-06
Observational study model:
Cohort
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
Study complete
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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