Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children

Study Overview
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Brief Summary
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The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.

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

Conditions
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Infections, Streptococcal

Intervention / Treatment
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* Procedure: Middle ear fluid and urine.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday. Signs, symptoms, and conditions: One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER Paradise's criteria, OR Spontaneous otorrhoea of less than 1 day. Onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment. Written informed consent obtained from parent(s) or Legally Acceptable Representative prior to study start. Exclusion Criteria: Hospitalised during the diagnosis of acute otitis media or during treatment, 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 3 days prior to enrolment, Receiving antimicrobial prophylaxis for recurrent acute otitis media, Provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea, Patients on antibiotics for acute otitis media who are clinically improving. Child in care.

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 |
| --- | --- |
| Cohort A<br>Subjects with a new episode of Acute Otitis Media (<3 days of onset) who have not yet received antibiotic therapy for the episode. | Procedure: Middle ear fluid and urine.<br>* Middle ear fluid and urine collection.<br>|
| Cohort B<br>Subjects who have had a diagnosis of Acute Otitis Media within 2-3 days prior to study enrolment and received antibiotic therapy, but remain symptomatic. | Procedure: Middle ear fluid and urine.<br>* Middle ear fluid and urine collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of bacterial pathogens isolated from middle ear fluid samples. |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of bacterial serotypes. |  | 12 Months | 
| Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques. |  | 12 Months | 
| Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. |  | 12 Months | 
| Occurrence of spontaneous otorrhoea. |  | 12 Months | 
| Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy. |  | 12 Months | 
| Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. |  | 12 Months |