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

NCT01365390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2258

Last updated 2014-07-28

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Estonia
  • Lithuania
  • Poland
  • Romania
  • Slovenia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01365390 on ClinicalTrials.gov