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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01365390
First received: May 31, 2011
Last updated: July 24, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Infections, Streptococcal
Other: Data collection (Retrospective)
Other: Data collection (Prospective)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of acute otitis media treatment failures [ Time Frame: Prospective data for 12 months after study entry ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2258
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365390

Locations
Estonia
GSK Investigational Site
Tallinn, Estonia, 10621
Lithuania
GSK Investigational Site
Vilnius, Lithuania, LT-04318
GSK Investigational Site
Vilnius, Lithuania, LT-03147
GSK Investigational Site
Vilnius, Lithuania, LT-07156
Poland
GSK Investigational Site
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
Romania
GSK Investigational Site
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
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
Ljubljana, Slovenia, 1210
GSK Investigational Site
Maribor, Slovenia
GSK Investigational Site
Maribor, Slovenia, 2000
GSK Investigational Site
Ptuj, Slovenia, 2250
GSK Investigational Site
Ruše, Slovenia, 2342
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01365390     History of Changes
Other Study ID Numbers: 115356
Study First Received: May 31, 2011
Last Updated: July 24, 2014
Health Authority: Romania : Ministerul Sanatatii - Comisia Nationala de Etica pentru Studiul Clinic al Medicamentului
Poland: Ministry of Health
Lithuania : Vilnius Regional Biomedical Research Ethics Committee

Keywords provided by GlaxoSmithKline:
prospective
Incidence
otitis
observational
Epidemiological
retrospective

Additional relevant MeSH terms:
Otitis Media
Streptococcal Infections
Bacterial Infections
Ear Diseases
Gram-Positive Bacterial Infections
Otitis
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014