To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries

CompletedOBSERVATIONAL
Enrollment

2,258

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Infections, Streptococcal
Interventions
OTHER

Data collection (Retrospective)

For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases. The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to \< 6 years) or since birth (for subjects aged \< 1 year) will be recorded in the electronic case report form.

OTHER

Data collection (Prospective)

For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject. In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded. The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire.

Trial Locations (25)

1000

GSK Investigational Site, Ljubljana

1210

GSK Investigational Site, Ljubljana

2000

GSK Investigational Site, Maribor

2250

GSK Investigational Site, Ptuj

2342

GSK Investigational Site, Ruše

10621

GSK Investigational Site, Tallinn

200128

GSK Investigational Site, Craiova

500260

GSK Investigational Site, Brasov

600316

GSK Investigational Site, Bacau

800394

GSK Investigational Site, Galati

LT-03147

GSK Investigational Site, Vilnius

LT-04318

GSK Investigational Site, Vilnius

LT-07156

GSK Investigational Site, Vilnius

85-796

GSK Investigational Site, Bydgoszcz

39-200

GSK Investigational Site, Dębica

40-018

GSK Investigational Site, Katowice

25-711

GSK Investigational Site, Kielce

41-103

GSK Investigational Site, Siemianowice Śląskie

33-100

GSK Investigational Site, Tarnów

01-809

GSK Investigational Site, Warsaw

84-200

GSK Investigational Site, Wejherowo

43-225

GSK Investigational Site, Wola

21-010

GSK Investigational Site, Łęczna

051821

GSK Investigational Site, Bucharest

Unknown

GSK Investigational Site, Maribor

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01365390 - To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries | Biotech Hunter | Biotech Hunter