Infections, StreptococcalNCT01365390
To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 25 sites in 5 countries.
Trial summary
The aim of this study is to provide baseline acute otitis media data in East European countries. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Data collection (Retrospective) and Data collection (Prospective)
- How many people
- 2,258 participants
- Where
- 25 sitesin 5 countries
- Study dates
- Jun 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Acute otitis media episode at the time of enrolment.
- Upper respiratory tract infection at the time of enrolment.
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
Poland10 sites
GSK Investigational Site
Bydgoszcz, 85-796
GSK Investigational Site
Dębica, 39-200
GSK Investigational Site
Katowice, 40-018
GSK Investigational Site
Kielce, 25-711
GSK Investigational Site
Łęczna, 21-010
GSK Investigational Site
Siemianowice Śląskie, 41-103
GSK Investigational Site
Tarnów, 33-100
GSK Investigational Site
Warsaw, 01-809
GSK Investigational Site
Wejherowo, 84-200
GSK Investigational Site
Wola, 43-225
Slovenia6 sites
GSK Investigational Site
Ljubljana, 1000
GSK Investigational Site
Ljubljana, 1210
GSK Investigational Site
Maribor, 2000
GSK Investigational Site
Maribor
GSK Investigational Site
Ptuj, 2250
GSK Investigational Site
Ruše, 2342
Romania5 sites
GSK Investigational Site
Bacau, 600316
GSK Investigational Site
Brasov, 500260
GSK Investigational Site
Bucharest, 051821
GSK Investigational Site
Craiova, 200128
GSK Investigational Site
Galati, 800394
Lithuania3 sites
GSK Investigational Site
Vilnius, LT-03147
GSK Investigational Site
Vilnius, LT-04318
GSK Investigational Site
Vilnius, LT-07156
About this study
Official title: 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.
Read the detailed description
Each subject's involvement in this study will include a retrospective and prospective part.
- Conditions
- Infections, Streptococcal
- Being tested
- Data collection (Retrospective), Data collection (Prospective)
- Keywords
- prospective, Incidence, otitis, observational, Epidemiological, retrospective
- Medical subject headings
- Streptococcal Infections, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Data collection (Retrospective); Other: Data collection (Prospective) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Prospective data for 12 months after study entry
Occurrence of recurrent acute otitis media
Measured: 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
Measured: 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
Measured: 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
Measured: Prospective data for 12 months after study entry
Occurrence of acute otitis media as diagnosed by the study physician or any other doctor
Measured: Prospective data for 12 months after study entry
Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures
Measured: Prospective data for 12 months after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 2,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365390
- Sponsor's protocol ID
- 115356
- Status last verified
- May 2014
- First submitted
- 31 May 2011
- Last updated
- 28 Jul 2014
- Results posted
- No
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.
PubMed 27457584
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries
- ClinicalTrials.gov ID
- NCT01365390
- Acronym / sponsor ID
- 115356
- Conditions
- Infections, Streptococcal
- Keywords
- prospective, Incidence, otitis, observational, Epidemiological, retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,258 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Data collection (Retrospective), Other: Data collection (Prospective)Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia). |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Acute otitis media episode at the time of enrolment.
- Upper respiratory tract infection at the time of enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cohort A |
| 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. | Other | Cohort A |
Primary outcome
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
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
8 secondary outcomes
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
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
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
Occurrence of acute otitis media treatment failures
Time frame: 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
Time frame: 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
Time frame: Prospective data for 12 months after study entry
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Derived from this study: PubMed 27457584Usonis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Poland, Slovenia, Romania, Lithuania, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.