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

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 Saudi Arabia.

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

Conditions
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Infections, Streptococcal

Intervention / Treatment
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* Procedure: Sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. 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.

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 |
| --- | --- |
| Study Group<br> | Procedure: Sample collection<br>* Middle ear fluid and urine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 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