Infections, StreptococcalNCT01204385
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Saudi Arabia.
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 Saudi Arabia. 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?
- Sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2009to May 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
Who may be able to join
- A child will be eligible for inclusion if he/she meets the following criteria:
- Age: ≥ 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
- Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
- Written informed consent obtained from parent or guardian prior to study start.
Who cannot join
- The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
- Hospitalised during the diagnosis of AOM or during treatment,
- Otitis externa, or otitis media with effusion
- Presence of a transtympanic aerator
- Systemic antibiotic treatment received for a disease other than AOM in the 72 hours prior to enrolment,
- Receiving antimicrobial prophylaxis for recurrent AOM,
- Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit, prior to the sampling
- Patients on antibiotics for AOM who are clinically improving.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia
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 Saudi Arabia.
- Conditions
- Infections, Streptococcal
- Being tested
- Sample collection
- Keywords
- Non-typeable Haemophilus Influenzae, Acute Otitis Media, Streptococcus Pneumoniae, etiology
- Medical subject headings
- Streptococcal Infections, 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
Middle ear fluid and urine
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described Receives: Procedure: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
Measured: Average time frame: 12 months
Secondary outcomes (6)
Occurence of H. influenzae and S. pneumoniae serotypes
Measured: Average time frame: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques
Measured: Average time frame: 12 months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media (≥ 3 episodes in the last 6 months or ≥ 4 episodes in 12 months)
Measured: Average time frame: 12 months
Occurrence of spontaneous otorrhea
Measured: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy
Measured: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine
Measured: Average time frame: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
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
- 66 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
- NCT01204385
- Sponsor's protocol ID
- 111337
- Status last verified
- Jan 2014
- First submitted
- 16 Sep 2010
- Last updated
- 13 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. 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 Saudi Arabia
- ClinicalTrials.gov ID
- NCT01204385
- Acronym / sponsor ID
- 111337
- Conditions
- Infections, Streptococcal
- Keywords
- Non-typeable Haemophilus Influenzae, Acute Otitis Media, Streptococcus Pneumoniae, etiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Sep 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 Saudi Arabia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study 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
Key inclusion criteria (5 listed)
- Age: ≥ 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
- Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
- Written informed consent obtained from parent or guardian prior to study start.
Key exclusion criteria (8 listed)
- The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
- Hospitalised during the diagnosis of AOM or during treatment,
- Otitis externa, or otitis media with effusion
- Presence of a transtympanic aerator
- Systemic antibiotic treatment received for a disease other than AOM 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 collectionMiddle ear fluid and urine | Procedure or surgery | Study Group |
Primary outcome
Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
Time frame: Average time frame: 12 months
6 secondary outcomes
Occurence of H. influenzae and S. pneumoniae serotypes
Time frame: Average time frame: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques
Time frame: Average time frame: 12 months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media (≥ 3 episodes in the last 6 months or ≥ 4 episodes in 12 months)
Time frame: Average time frame: 12 months
Occurrence of spontaneous otorrhea
Time frame: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy
Time frame: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine
Time frame: Average time frame: 12 months
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 13 Jan 2014.
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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
1 site 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 1 site in Saudi Arabia.
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 5 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: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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 H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples (time frame: Average time frame: 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 13 Jan 2014.