Clinical trial NCT01365390: To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
Official title: To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Streptococcal
Keywords: prospective
Incidence
otitis
observational
Epidemiological
retrospective
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 2258
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
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.

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

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

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 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
measure: Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study
timeFrame: Prospective data for 12 months after study entry
Secondary outcomes:
measure: Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year
timeFrame: Prospective data for 12 months after study entry
measure: 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
timeFrame: Prospective data for 12 months after study entry
measure: Occurrence of recurrent acute otitis media
timeFrame: 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
measure: Occurrence of acute otitis media treatment failures
timeFrame: Prospective data for 12 months after study entry
measure: 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
timeFrame: Prospective data for 12 months after study entry
measure: Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media
timeFrame: Prospective data for 12 months after study entry
measure: Occurrence of acute otitis media as diagnosed by the study physician or any other doctor
timeFrame: Prospective data for 12 months after study entry
measure: Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures
timeFrame: Prospective data for 12 months after study entry
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Leczna
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wejherowo
country: Poland
facility: GSK Investigational Site
city: Wola
country: Poland
facility: GSK Investigational Site
city: Bacau
country: Romania
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Ljubljana
country: Slovenia
facility: GSK Investigational Site
city: Ljubljana
country: Slovenia
facility: GSK Investigational Site
city: Maribor
country: Slovenia
facility: GSK Investigational Site
city: Maribor
country: Slovenia
facility: GSK Investigational Site
city: Ptuj
country: Slovenia
facility: GSK Investigational Site
city: Ruše
country: Slovenia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.