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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Streptococcal

Treatments: Other: Data collection (Prospective); Other: Data collection (Retrospective)

Study type: Observational

Funder types: Industry

Identifiers

NCT01365390

115356

Details and patient eligibility

About

The aim of this study is to provide baseline acute otitis media data in East European countries.

Full description

Each subject's involvement in this study will include a retrospective and prospective part.

Enrollment: 2,258 patients

Sex: All

Ages: Under 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion 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.
• 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.

Exclusion criteria

• Acute otitis media episode at the time of enrolment.
• Upper respiratory tract infection at the time of enrolment.

Trial design

2,258 participants in 1 patient group

Cohort A

Description:

Subjects aged \< 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia).

Treatment:

Other: Data collection (Retrospective)

Other: Data collection (Prospective)