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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01733849
First received: November 21, 2012
Last updated: October 16, 2014
Last verified: September 2014
  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). ] [ Designated as safety issue: No ]

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). ] [ 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 ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: October 16, 2014
Health Authority: Bulgaria: Ministry of Health
Latvia: Central Medical Ethics Committee

Keywords provided by GlaxoSmithKline:
Bulgaria
Latvia
Primary care settings
Children
Acute gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Digestive System Diseases
Gastrointestinal Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014