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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection | Procedure | Middle ear fluid and urine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples | Average time frame: 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of H. influenzae and S. pneumoniae serotypes | 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 |
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Inclusion Criteria:
A child will be eligible for inclusion if he/she meets the following criteria:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
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Subjects aged ≥ 3 months and < 5 years of age, diagnosed as having AOM
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Riyadh | Saudi Arabia |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Middle ear fluid and urine
| 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) | Average time frame: 12 months |
| Occurrence of spontaneous otorrhea | 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 | Average time frame: 12 months |
| Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine | Average time frame: 12 months |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |