Infections, StreptococcalNCT01031329
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 8 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Tympanocenthesis and urine collection
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- Nov 2012to Feb 2014
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects aged >= 3 months and < 5 years, diagnosed as having complicated acute otitis media on routine clinical care in the study hospitals.
Who may be able to join
- Age: >= 3 months and < 5 years at the time they are seen by the paediatrician. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions:
- One of the functional or general signs of otalgia ,conjunctivitis, fever and either
- Paradise's criteria or
- Spontaneous otorrhoea of less than 24 hours.
- Subjects if classified as recurrent acute otitis media or treatment failure as described below:
Show all 9Show fewer
- Recurrent acute otitis media: Defined as a subject who has an episode of acute otitis media representing the third new episode within the past 6 months, or the fourth new episode within the past year.
- Treatment failure: Defined as a subject who was diagnosed with acute otitis media and received antibiotic treatment from a physician, but is still symptomatic 48-72 hours after initiation of the treatment. As with other acute otitis media cases, the onset of signs or symptoms should have been within 72 hours prior to the initial visit to the physician.
- Written informed consent obtained from parent or guardian prior to study start.
Who cannot join
- Hospitalised during the diagnosis of acute otitis media or during treatment.
- Otitis externa, or otitis media with effusion.
- Presence of a transtympanic aerator.
- Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
- Receiving antimicrobial prophylaxis for recurrent acute otitis media.
- Provision of antibiotic by paediatrician at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous otorrhoea.
- Patients that are on antibiotics for acute otitis media, and are clinically improving.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites
GSK Investigational Site
Adana, 1330
GSK Investigational Site
Adana
GSK Investigational Site
Ankara, 6100
GSK Investigational Site
Ankara
GSK Investigational Site
Istanbul, 34280
GSK Investigational Site
Istanbul
GSK Investigational Site
Izmir, 35100
GSK Investigational Site
Izmir
About this study
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Turkey
The purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.
- Conditions
- Infections, Streptococcal
- Being tested
- Tympanocenthesis and urine collection
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanocenthesis and urine collectionProcedure or surgery
Fluid using needle aspiration is obtained from middle ear fluid. Urine is collected using a urine bag.
| Study group | Role | What they receive |
|---|---|---|
| Complicated Acute otitis media Group | This group was divided into 3 sub-groups.
* One sub-group includes treatment failure subjects who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment or reappearance of symptoms within 10 days following the end of antibiotic treatment.
* The second sub-group includes subjects with recurrent acute otitis media, who have had new episodes of acute otitis media within the past 6 months or the fourth (or greater) new episode within the past year.
* The third sub-group includes subjects with spontaneous otorrhoea if perforation has occurred < 24 hours prior to the visit. Receives: Procedure: Tympanocenthesis and urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of bacterial pathogens isolated from middle ear fluid samples.
Secondary outcomes (5)
Occurrence of bacterial serotypes.
Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples collected from sub-groups of complicated acute otitis media cases.
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Occurrence of spontaneous otorrhoea.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startNov 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT01031329
- Sponsor's protocol ID
- 111339
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 2009
- Last updated
- 13 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Turkey
- ClinicalTrials.gov ID
- NCT01031329
- Acronym / sponsor ID
- 111339
- Conditions
- Infections, Streptococcal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 14 Dec 2009 (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 purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complicated Acute otitis media Group | – | Procedure: Tympanocenthesis and urine collectionThis group was divided into 3 sub-groups. * One sub-group includes treatment failure subjects who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment or reappearance of symptoms within 10 days following the end of antibiotic treatment. * The second sub-group includes subjects with recurrent acute otitis media, who have had new episodes of acute otitis media within the past 6 months or the fourth (or greater) new episode within the past year. * The third sub-group includes subjects with spontaneous otorrhoea if perforation has occurred < 24 hours prior to the visit. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects aged >= 3 months and < 5 years, diagnosed as having complicated acute otitis media on routine clinical care in the study hospitals.
Key inclusion criteria (9 listed)
- Age: >= 3 months and < 5 years at the time they are seen by the paediatrician. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions:
- One of the functional or general signs of otalgia ,conjunctivitis, fever and either
- Paradise's criteria or
- Spontaneous otorrhoea of less than 24 hours.
Key exclusion criteria (7 listed)
- Hospitalised during the diagnosis of acute otitis media or during treatment.
- Otitis externa, or otitis media with effusion.
- Presence of a transtympanic aerator.
- Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
- Receiving antimicrobial prophylaxis for recurrent acute otitis media.
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 |
|---|---|---|
| Tympanocenthesis and urine collectionFluid using needle aspiration is obtained from middle ear fluid. Urine is collected using a urine bag. | Procedure or surgery | Complicated Acute otitis media Group |
Primary outcome
Occurrence of bacterial pathogens isolated from middle ear fluid samples.
5 secondary outcomes
Occurrence of bacterial serotypes.
Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples collected from sub-groups of complicated acute otitis media cases.
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Occurrence of spontaneous otorrhoea.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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
8 sites in 1 country: 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 8 sites in Turkey (Türkiye).
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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). 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 was withdrawn before enrolling participants, so there are no results.
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 bacterial pathogens isolated from middle ear fluid samples.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2015.