To evaluate the incidence of acute otitis media in children in five East European countries
Trial overview
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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Prospective data for 12 months after study entry
Occurrence of recurrent acute otitis media
Timeframe: 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
Timeframe: 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
Timeframe: Prospective data for 12 months after study entry
Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media
Timeframe: Prospective data for 12 months after study entry
Occurrence of acute otitis media as diagnosed by the study physician or any other doctor
Timeframe: Prospective data for 12 months after study entry
Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures
Timeframe: Prospective data for 12 months after study entry
Participation criteria
- Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- A male or female subject aged < 6 years at the time of enrolment.
- Acute otitis media episode at the time of enrolment.
- Upper respiratory tract infection at the time of enrolment.
- Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- A male or female subject aged < 6 years at the time of enrolment.
- The investigator has access to the medical records that contain the medical history of the subjects for one year prior to enrolment (for subjects aged 1 to < 6 years) or from birth (for subjects aged < 1 year).
- Written informed consent obtained from either both parents/ LARs or from one parent/ LAR of the subject with the declaration of cooperation for one year after enrolment.
- Acute otitis media episode at the time of enrolment.
- Upper respiratory tract infection at the time of enrolment.
Trial location(s)
Study documents
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Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.