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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01733849
Other study ID # 116621
Secondary ID
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
Health authority
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.

Study Design


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).
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