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Completed

NCT Number: NCT01365390

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

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

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Ear Diseases Gram-Positive Bacterial Infections Infections Otitis Otorhinolaryngologic Diseases Streptococcal Infections

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Tallinn, Estonia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection (retrospective)

Other

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.

Data collection (prospective)

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Occurrence of acute otitis media treatment failures

    Time frame: Prospective data for 12 months after study entry

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2011
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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