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

Infections, Streptococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365390
• Other study ID #: 115356
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: July 24, 2014
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania : Ministerul Sanatatii - Comisia Nationala de Etica pentru Studiul Clinic al MedicamentuluiPoland: Ministry of HealthLithuania : Vilnius Regional Biomedical Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2258
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Infections, Streptococcal
• Otitis Media
• Streptococcal Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Tallinn
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Kielce
Poland	GSK Investigational Site	Leczna
Poland	GSK Investigational Site	Siemianowice Slaskie
Poland	GSK Investigational Site	Tarnow
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wejherowo
Poland	GSK Investigational Site	Wola
Romania	GSK Investigational Site	Bacau
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Galati
Slovenia	GSK Investigational Site	Ljubljana
Slovenia	GSK Investigational Site	Ljubljana
Slovenia	GSK Investigational Site	Maribor
Slovenia	GSK Investigational Site	Maribor
Slovenia	GSK Investigational Site	Ptuj
Slovenia	GSK Investigational Site	Ruše

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Estonia,  Lithuania,  Poland,  Romania,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Occurrence of acute otitis media treatment failures		Prospective data for 12 months after study entry	No
Secondary	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	No
Secondary	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	No
Secondary	Occurrence of acute otitis media as diagnosed by the study physician or any other doctor		Prospective data for 12 months after study entry	No
Secondary	Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures		Prospective data for 12 months after study entry	No