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

NCT01733849 | Completed

• 1 other identifier: 116621
• Study Type: observational
• Target: 1,266
• Locations: 2 countries
• Sites: 57

Brief 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.

Conditions

Infections, Rotavirus

Keywords

Bulgaria; Primary care settings; Children; Latvia; Acute gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (2)

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; Other: Data collection

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; Other: Data collection

Interventions

Stool sample OTHER

Samples will be tested to determine the presence or absence of rotavirus.

Group Bulgaria; Group Latvia

Data collection OTHER

Log books

Group Bulgaria; Group Latvia

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Child in care.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (57)

GSK Investigational Site

Burgas, 8000, Bulgaria

Location

GSK Investigational Site

Burgas, 8018, Bulgaria

Location

GSK Investigational Site

Dobrich, 9300, Bulgaria

Location

GSK Investigational Site

Pazardzhik, 4400, Bulgaria

Location

GSK Investigational Site

Pleven, 5800, Bulgaria

Location

GSK Investigational Site

Plovdiv, 4000, Bulgaria

Location

GSK Investigational Site

Rousse, 7000, Bulgaria

Location

GSK Investigational Site

Sliven, 8800, Bulgaria

Location

GSK Investigational Site

Sofia, 1505, Bulgaria

Location

GSK Investigational Site

Sofia, 1517, Bulgaria

Location

GSK Investigational Site

Sofia, 1528, Bulgaria

Location

GSK Investigational Site

Sofia, 1606, Bulgaria

Location

GSK Investigational Site

Stara Zagora, 6000, Bulgaria

Location

GSK Investigational Site

Varna, 9000, Bulgaria

Location

GSK Investigational Site

Veliko Tarnovo, 5000, Bulgaria

Location

GSK Investigational Site

Balvi, LV-4501, Latvia

Location

GSK Investigational Site

Bauska, LV-3901, Latvia

Location

GSK Investigational Site

Brocēni, LV-3851, Latvia

Location

GSK Investigational Site

Carnikava, LV-2163, Latvia

Location

GSK Investigational Site

Daugavpils, LV-5401, Latvia

Location

GSK Investigational Site

Daugavpils, LV-5410, Latvia

Location

GSK Investigational Site

Druva, LV-3862, Latvia

Location

GSK Investigational Site

Erglu Pagasts, LV-4840, Latvia

Location

GSK Investigational Site

Grobiņa, LV-3430, Latvia

Location

GSK Investigational Site

Ikšķile, LV-5052, Latvia

Location

GSK Investigational Site

Jelgava, LV-3001, Latvia

Location

GSK Investigational Site

Jelgava, LV-3002, Latvia

Location

GSK Investigational Site

Jelgava, LV-3007, Latvia

Location

GSK Investigational Site

Jelgava, LV-3008, Latvia

Location

GSK Investigational Site

Jēkabpils, LV-5201, Latvia

Location

GSK Investigational Site

Kuldīga, LV-3300, Latvia

Location

GSK Investigational Site

Liepāja, LV-3401, Latvia

Location

GSK Investigational Site

Limbaži, LV-4001, Latvia

Location

GSK Investigational Site

Līvāni, LV-5316, Latvia

Location

GSK Investigational Site

Madona, LV-4801, Latvia

Location

GSK Investigational Site

Ogre, LV-5001, Latvia

Location

GSK Investigational Site

Ozolnieki, LV-3018, Latvia

Location

GSK Investigational Site

Piņķi, LV-2107, Latvia

Location

GSK Investigational Site

Rēzekne, LV-4601, Latvia

Location

GSK Investigational Site

Rēzekne, LV-4604, Latvia

Location

GSK Investigational Site

Riga, LV-1001, Latvia

Location

GSK Investigational Site

Riga, LV-1002, Latvia

Location

GSK Investigational Site

Riga, LV-1010, Latvia

Location

GSK Investigational Site

Riga, LV-1011, Latvia

Location

GSK Investigational Site

Riga, LV-1012, Latvia

Location

GSK Investigational Site

Riga, LV-1024, Latvia

Location

GSK Investigational Site

Riga, LV-1050, Latvia

Location

GSK Investigational Site

Riga, LV-1063, Latvia

Location

GSK Investigational Site

Riga, LV-1082, Latvia

Location

GSK Investigational Site

Ropaži, LV-2135, Latvia

Location

GSK Investigational Site

Sigulda, LV-2150, Latvia

Location

GSK Investigational Site

Tukums, LV-3101, Latvia

Location

GSK Investigational Site

Valmiera, LV-4200, Latvia

Location

GSK Investigational Site

Valmiera, LV-4201, Latvia

Location

GSK Investigational Site

Vangaži, LV-2136, Latvia

Location

GSK Investigational Site

Ventspils, LV-3601, Latvia

Location

GSK Investigational Site

Ventspils, LV-3602, Latvia

Location

Related Publications (2)

• Tafalla M, Gardovska D, Gopala K, Kozlovska L. Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis. Hum Vaccin Immunother. 2019;15(6):1272-1278. doi: 10.1080/21645515.2018.1534515. Epub 2018 Oct 31.

  PMID: 30335570 DERIVED

• Tiholova M, Gopala K, Berberova M, Strokova-Stoilova M, Tafalla M. Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study. Germs. 2016 Sep 1;6(3):97-105. doi: 10.11599/germs.2016.1095. eCollection 2016 Sep.

  PMID: 27622162 DERIVED

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

LA (42); BU (15)