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

NCT01365390 | Completed

• 1 other identifier: 115356
• Study Type: observational
• Target: 2,258
• Locations: 5 countries
• Sites: 25

Brief Summary

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

Conditions

Infections, Streptococcal

Keywords

prospective; Incidence; otitis; observational; Epidemiological; retrospective

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (1)

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); Other: Data collection (Prospective)

Interventions

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.

Cohort A

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.

Cohort A

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (25)

GSK Investigational Site

Tallinn, 10621, Estonia

Location

GSK Investigational Site

Vilnius, LT-03147, Lithuania

Location

GSK Investigational Site

Vilnius, LT-04318, Lithuania

Location

GSK Investigational Site

Vilnius, LT-07156, Lithuania

Location

GSK Investigational Site

Bydgoszcz, 85-796, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Katowice, 40-018, Poland

Location

GSK Investigational Site

Kielce, 25-711, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Warsaw, 01-809, Poland

Location

GSK Investigational Site

Wejherowo, 84-200, Poland

Location

GSK Investigational Site

Wola, 43-225, Poland

Location

GSK Investigational Site

Łęczna, 21-010, Poland

Location

GSK Investigational Site

Bacau, 600316, Romania

Location

GSK Investigational Site

Brasov, 500260, Romania

Location

GSK Investigational Site

Bucharest, 051821, Romania

Location

GSK Investigational Site

Craiova, 200128, Romania

Location

GSK Investigational Site

Galati, 800394, Romania

Location

GSK Investigational Site

Ljubljana, 1000, Slovenia

Location

GSK Investigational Site

Ljubljana, 1210, Slovenia

Location

GSK Investigational Site

Maribor, 2000, Slovenia

Location

GSK Investigational Site

Maribor, Slovenia

Location

GSK Investigational Site

Ptuj, 2250, Slovenia

Location

GSK Investigational Site

Ruše, 2342, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 27457584 DERIVED

MeSH Terms

Conditions

Streptococcal Infections; Otitis

Interventions

Data Collection; Retrospective Studies; Longitudinal Studies

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Cohort Studies

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 28, 2014

Record last verified: 2014-05

Locations

SL (6); LI (3); ES (1); PL (10); RO (5)