The aim of this study is to provide baseline acute otitis media data in East European countries.
Each subject's involvement in this study will include a retrospective and prospective part.
Study Type
OBSERVATIONAL
Enrollment
2,258
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.
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.
GSK Investigational Site
Tallinn, Estonia
Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by a family physician and documented in medical records - retrospective part of the study
Time frame: Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year
Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study
Time frame: Prospective data for 12 months after study entry
Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year
Time frame: Prospective data for 12 months after study entry
Occurrence of suspected acute otitis media as reported by the parent(s)/ legally acceptable representative(s) (and not diagnosed by any physician) during the bi-monthly follow-up
Time frame: Prospective data for 12 months after study entry
Occurrence of recurrent acute otitis media
Time frame: Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry
Occurrence of acute otitis media treatment failures
Time frame: Prospective data for 12 months after study entry
Assessment of the impact of acute otitis media on the quality of life of the subject and family by the parental quality of life questionnaire and the Otitis Media-6 children's quality of life questionnaire
Time frame: Prospective data for 12 months after study entry
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GSK Investigational Site
Vilnius, Lithuania
GSK Investigational Site
Vilnius, Lithuania
GSK Investigational Site
Vilnius, Lithuania
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Dębica, Poland
GSK Investigational Site
Katowice, Poland
GSK Investigational Site
Kielce, Poland
GSK Investigational Site
Siemianowice Śląskie, Poland
GSK Investigational Site
Tarnów, Poland
...and 15 more locations
Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media
Time frame: Prospective data for 12 months after study entry
Occurrence of acute otitis media as diagnosed by the study physician or any other doctor
Time frame: Prospective data for 12 months after study entry
Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures
Time frame: Prospective data for 12 months after study entry