A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

January 16, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • GSK Investigational Site
      • Burgas, Bulgaria, 8018
        • GSK Investigational Site
      • Dobrich, Bulgaria, 9300
        • GSK Investigational Site
      • Pazardzik, Bulgaria, 4400
        • GSK Investigational Site
      • Pleven, Bulgaria, 5800
        • GSK Investigational Site
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Ruse, Bulgaria, 7000
        • GSK Investigational Site
      • Sliven, Bulgaria, 8800
        • GSK Investigational Site
      • Sofia, Bulgaria, 1606
        • GSK Investigational Site
      • Sofia, Bulgaria, 1505
        • GSK Investigational Site
      • Sofia, Bulgaria, 1517
        • GSK Investigational Site
      • Sofia, Bulgaria, 1528
        • GSK Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • GSK Investigational Site
      • Varna, Bulgaria, 9000
        • GSK Investigational Site
      • Veliko Turnovo, Bulgaria, 5000
        • GSK Investigational Site
  • Latvia
      • Balvi, Latvia, LV-4501
        • GSK Investigational Site
      • Bauska, Latvia, LV-3901
        • GSK Investigational Site
      • Broceni, Latvia, LV-3851
        • GSK Investigational Site
      • Carnikava, Latvia, LV-2163
        • GSK Investigational Site
      • Daugavpils, Latvia, LV-5401
        • GSK Investigational Site
      • Daugavpils, Latvia, LV-5410
        • GSK Investigational Site
      • Druva, Latvia, LV-3862
        • GSK Investigational Site
      • Erglu pagasts, Latvia, LV-4840
        • GSK Investigational Site
      • Grobina, Latvia, LV-3430
        • GSK Investigational Site
      • Ikskile, Latvia, LV-5052
        • GSK Investigational Site
      • Jekabpils, Latvia, LV-5201
        • GSK Investigational Site
      • Jelgava, Latvia, LV-3001
        • GSK Investigational Site
      • Jelgava, Latvia, LV-3002
        • GSK Investigational Site
      • Jelgava, Latvia, LV-3007
        • GSK Investigational Site
      • Jelgava, Latvia, LV-3008
        • GSK Investigational Site
      • Kuldiga, Latvia, LV-3300
        • GSK Investigational Site
      • Liepaja, Latvia, LV-3401
        • GSK Investigational Site
      • Limbazi, Latvia, LV-4001
        • GSK Investigational Site
      • Livani, Latvia, LV-5316
        • GSK Investigational Site
      • Madona, Latvia, LV-4801
        • GSK Investigational Site
      • Ogre, Latvia, LV-5001
        • GSK Investigational Site
      • Ozolnieki, Latvia, LV-3018
        • GSK Investigational Site
      • Pinki, Latvia, LV-2107
        • GSK Investigational Site
      • Rezekne, Latvia, LV-4601
        • GSK Investigational Site
      • Rezekne, Latvia, LV-4604
        • GSK Investigational Site
      • Riga, Latvia, LV-1001
        • GSK Investigational Site
      • Riga, Latvia, LV-1002
        • GSK Investigational Site
      • Riga, Latvia, LV-1010
        • GSK Investigational Site
      • Riga, Latvia, LV-1011
        • GSK Investigational Site
      • Riga, Latvia, LV-1012
        • GSK Investigational Site
      • Riga, Latvia, LV-1024
        • GSK Investigational Site
      • Riga, Latvia, LV-1050
        • GSK Investigational Site
      • Riga, Latvia, LV-1063
        • GSK Investigational Site
      • Riga, Latvia, LV-1082
        • GSK Investigational Site
      • Ropazi, Latvia, LV-2135
        • GSK Investigational Site
      • Sigulda, Latvia, LV-2150
        • GSK Investigational Site
      • Tukums, Latvia, LV-3101
        • GSK Investigational Site
      • Valmiera, Latvia, LV-4200
        • GSK Investigational Site
      • Valmiera, Latvia, LV-4201
        • GSK Investigational Site
      • Vangazi, Latvia, LV-2136
        • GSK Investigational Site
      • Ventspils, Latvia, LV-3601
        • GSK Investigational Site
      • Ventspils, Latvia, LV-3602
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
At the time of enrollment of each subject (Day 0).

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
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).
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).
At the time of phone call follow-up contact (14 to 19 days after enrollment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116621

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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