Acute Otitis MediaNCT01072227
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan
An observational study of Acute Otitis Media, run by GlaxoSmithKline at 2 sites in Taiwan.
Trial summary
The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media episodes in young children aged >= 3 months to < 5 years in Taiwan Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Sample Collection
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jul 2010to Apr 2011
- 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 of age, diagnosed as having AOM in hospital by pediatricians or ear nose and throat (ENT) specialists.
Who may be able to join
- Age: >= 3 months and < 5 years at the time they are seen by the pediatrician or ear, nose and throat specialist. The subject becomes ineligible on the fifth birthday.
- Onset of signs and symptoms of acute otitis media within 72 hours:
- One of the functional or general signs of otalgia (, conjunctivitis, fever and either
- Paradise's criteria or
- Spontaneous otorrhea of less than 1 day.
- Written informed consent obtained from parent or legally acceptable representative prior to study start.
Who cannot join
- Hospitalized during the diagnosis of acute otitis media.
- Onset of otorrhea greater than 1 day prior to enrolment.
- 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 prescribing antibiotics by ear, nose and throat specialist and Pediatricians for acute otitis media before sample collection.
- Intended or planned prescription of antibiotic by pediatrician or ear, nose and throat specialist prior to the completion of study specified procedures during the enrolment visit.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
GSK Investigational Site
Taipei
GSK Investigational Site
Taoyuan Hsien
About this study
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan
The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media episodes in young children aged >= 3 months to < 5 years in Taiwan
- Conditions
- Acute Otitis Media
- Being tested
- Sample Collection
- Keywords
- Non-typeable Haemophilus Influenzae, Acute Otitis Media, Streptococcus Pneumoniae, Etiology
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample CollectionProcedure or surgery
Tissue
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Not described Receives: Procedure: Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
Measured: Average duration: 12 months
Secondary outcomes (6)
Distribution of H. influenzae and S. pneumoniae serotypes.
Measured: Average duration: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis
Measured: Average duration: 12 months
Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM
Measured: Average duration: 12 months
Occurrence of spontaneous otorrhea
Measured: Average duration: 12 months
Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy
Measured: Average duration: 12 months
Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.
Measured: Average duration: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: The study was terminated for logistic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies 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
- 10 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
- NCT01072227
- Sponsor's protocol ID
- 113932
- Status last verified
- May 2017
- First submitted
- 18 Feb 2010
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. 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 Taiwan
- ClinicalTrials.gov ID
- NCT01072227
- Acronym / sponsor ID
- 113932
- Conditions
- Acute Otitis Media
- Keywords
- Non-typeable Haemophilus Influenzae, Acute Otitis Media, Streptococcus Pneumoniae, Etiology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated for logistic reasons
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Feb 2010 (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 the study is to identify the bacterial aetiology of Acute Otitis Media episodes in young children aged >= 3 months to < 5 years in Taiwan
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | Procedure: Sample Collection |
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 of age, diagnosed as having AOM in hospital by pediatricians or ear nose and throat (ENT) specialists.
Key inclusion criteria (6 listed)
- Age: >= 3 months and < 5 years at the time they are seen by the pediatrician or ear, nose and throat specialist. The subject becomes ineligible on the fifth birthday.
- Onset of signs and symptoms of acute otitis media within 72 hours:
- One of the functional or general signs of otalgia (, conjunctivitis, fever and either
- Paradise's criteria or
- Spontaneous otorrhea of less than 1 day.
Key exclusion criteria (8 listed)
- Hospitalized during the diagnosis of acute otitis media.
- Onset of otorrhea greater than 1 day prior to enrolment.
- 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.
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 |
|---|---|---|
| Sample CollectionTissue | Procedure or surgery | Single Group |
Primary outcome
Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
Time frame: Average duration: 12 months
6 secondary outcomes
Distribution of H. influenzae and S. pneumoniae serotypes.
Time frame: Average duration: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis
Time frame: Average duration: 12 months
Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM
Time frame: Average duration: 12 months
Occurrence of spontaneous otorrhea
Time frame: Average duration: 12 months
Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy
Time frame: Average duration: 12 months
Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.
Time frame: Average duration: 12 months
Results and safety
The study was stopped early (reason given: The study was terminated for logistic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Otitis Media, run by GlaxoSmithKline at 2 sites in Taiwan.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 stopped early (reason given: The study was terminated for logistic reasons). Results are not available in the source record.
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?
Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens (time frame: Average duration: 12 months). 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 30 May 2017.