Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan

Study Overview
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Brief Summary
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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 Taiwan

Official Title
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Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Procedure: Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Group<br> | Procedure: Sample Collection<br>* Tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens |  | Average duration: 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of H. influenzae and S. pneumoniae serotypes. |  | Average duration: 12 months | 
| Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis |  | Average duration: 12 months | 
| Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM |  | Average duration: 12 months | 
| Occurrence of spontaneous otorrhea |  | Average duration: 12 months | 
| Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy |  | Average duration: 12 months | 
| Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine. |  | Average duration: 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-typeable Haemophilus Influenzae, Acute Otitis Media, Streptococcus Pneumoniae, Etiology