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

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733849
• Other study ID #: 116621
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: January 16, 2017
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1266
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections

Intervention

Other:
• Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
• Data collection
Log books

Locations

Country	Name	City	State
Bulgaria	GSK Investigational Site	Burgas
Bulgaria	GSK Investigational Site	Burgas
Bulgaria	GSK Investigational Site	Dobrich
Bulgaria	GSK Investigational Site	Pazardzik
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Ruse
Bulgaria	GSK Investigational Site	Sliven
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Stara Zagora
Bulgaria	GSK Investigational Site	Varna
Bulgaria	GSK Investigational Site	Veliko Turnovo
Latvia	GSK Investigational Site	Balvi
Latvia	GSK Investigational Site	Bauska
Latvia	GSK Investigational Site	Broceni
Latvia	GSK Investigational Site	Carnikava
Latvia	GSK Investigational Site	Daugavpils
Latvia	GSK Investigational Site	Daugavpils
Latvia	GSK Investigational Site	Druva
Latvia	GSK Investigational Site	Erglu pagasts
Latvia	GSK Investigational Site	Grobina
Latvia	GSK Investigational Site	Ikskile
Latvia	GSK Investigational Site	Jekabpils
Latvia	GSK Investigational Site	Jelgava
Latvia	GSK Investigational Site	Jelgava
Latvia	GSK Investigational Site	Jelgava
Latvia	GSK Investigational Site	Jelgava
Latvia	GSK Investigational Site	Kuldiga
Latvia	GSK Investigational Site	Liepaja
Latvia	GSK Investigational Site	Limbazi
Latvia	GSK Investigational Site	Livani
Latvia	GSK Investigational Site	Madona
Latvia	GSK Investigational Site	Ogre
Latvia	GSK Investigational Site	Ozolnieki
Latvia	GSK Investigational Site	Pinki
Latvia	GSK Investigational Site	Rezekne
Latvia	GSK Investigational Site	Rezekne
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Ropazi
Latvia	GSK Investigational Site	Sigulda
Latvia	GSK Investigational Site	Tukums
Latvia	GSK Investigational Site	Valmiera
Latvia	GSK Investigational Site	Valmiera
Latvia	GSK Investigational Site	Vangazi
Latvia	GSK Investigational Site	Ventspils
Latvia	GSK Investigational Site	Ventspils

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Bulgaria,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At the time of enrollment of each subject (Day 0).
Secondary	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.		Day 0 - Day 14+5 (At the time of phone call follow-up contact).
Secondary	Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.		At the time of enrollment of each subject (Day 0).
Secondary	Number of hospitalisations for RV GE and AGE, reported at the primary care settings.		At the time of phone call follow-up contact (14 to 19 days after enrollment).