Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan
Terminated
- Conditions
- Acute Otitis Media
- Registration Number
- NCT01072227
- Lead Sponsor
- GlaxoSmithKline
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens Average duration: 12 months
- Secondary Outcome Measures
Name Time Method Distribution of H. influenzae and S. pneumoniae serotypes. Average duration: 12 months 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 Occurrence of spontaneous otorrhea Average duration: 12 months Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine. 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇳Taoyuan Hsien, Taiwan
GSK Investigational Site🇨🇳Taoyuan Hsien, Taiwan