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

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

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.

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.