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

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

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

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Other: Data collection (Retrospective); Other: Data collection (Prospective)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 2258

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10621
    • GSK Investigational Site
• Lithuania
  • Vilnius, Lithuania, LT-07156
    • GSK Investigational Site
  • Vilnius, Lithuania, LT-04318
    • GSK Investigational Site
  • Vilnius, Lithuania, LT-03147
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • GSK Investigational Site
  • Debica, Poland, 39-200
    • GSK Investigational Site
  • Katowice, Poland, 40-018
    • GSK Investigational Site
  • Kielce, Poland, 25-711
    • GSK Investigational Site
  • Leczna, Poland, 21-010
    • GSK Investigational Site
  • Siemianowice Slaskie, Poland, 41-103
    • GSK Investigational Site
  • Tarnow, Poland, 33-100
    • GSK Investigational Site
  • Warszawa, Poland, 01-809
    • GSK Investigational Site
  • Wejherowo, Poland, 84-200
    • GSK Investigational Site
  • Wola, Poland, 43-225
    • GSK Investigational Site
• Romania
  • Bacau, Romania, 600316
    • GSK Investigational Site
  • Brasov, Romania, 500260
    • GSK Investigational Site
  • Bucharest, Romania, 051821
    • GSK Investigational Site
  • Craiova, Romania, 200128
    • GSK Investigational Site
  • Galati, Romania, 800394
    • GSK Investigational Site
• Slovenia
  • Ljubljana, Slovenia, 1000
    • GSK Investigational Site
  • Ljubljana, Slovenia, 1210
    • GSK Investigational Site
  • Maribor, Slovenia, 2000
    • GSK Investigational Site
  • Maribor, Slovenia
    • GSK Investigational Site
  • Ptuj, Slovenia, 2250
    • GSK Investigational Site
  • Ruše, Slovenia, 2342
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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	Prospective data for 12 months after study entry

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year	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	Prospective data for 12 months after study entry
Occurrence of recurrent acute otitis media	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	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	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	Prospective data for 12 months after study entry
Occurrence of acute otitis media as diagnosed by the study physician or any other doctor	Prospective data for 12 months after study entry
Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures	Prospective data for 12 months after study entry

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Usonis V, Jackowska T, Petraitiene S, Sapala A, Neculau A, Stryjewska I, Devadiga R, Tafalla M, Holl K. Incidence of acute otitis media in children below 6 years of age seen in medical practices in five East European countries. BMC Pediatr. 2016 Jul 26;16:108. doi: 10.1186/s12887-016-0638-2.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Incidence; prospective; observational; Epidemiological; otitis; retrospective
• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Ear Diseases; Otitis; Otitis Media; Streptococcal Infections
• Other Study ID Numbers: 115356