Acute Otitis Media
Conditions
Keywords
Non-typeable Haemophilus Influenzae, Acute Otitis Media, Streptococcus Pneumoniae, Etiology
Brief summary
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
Interventions
PROCEDURESample Collection
Tissue
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens | Average duration: 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Distribution of H. influenzae and S. pneumoniae serotypes. | 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 |
| Occurrence of spontaneous otorrhea | Average duration: 12 months |
Countries
Taiwan
Outcome results
None listed