Infections, Streptococcal
Conditions
Brief summary
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.
Interventions
PROCEDUREMiddle ear fluid and urine.
Middle ear fluid and urine collection.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of bacterial pathogens isolated from middle ear fluid samples. | 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 bacterial serotypes. | 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 |
| Occurrence of spontaneous otorrhoea. | 12 Months |
Outcome results
None listed