Acute Otitis Media Clinical Trial
Official title:
Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan
Verified date | May 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Terminated |
Enrollment | 10 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 5 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | GSK Investigational Site | Taipei | |
Taiwan | GSK Investigational Site | Taoyuan Hsien |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens | Average duration: 12 months | ||
Secondary | Distribution of H. influenzae and S. pneumoniae serotypes. | Average duration: 12 months | ||
Secondary | Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis | Average duration: 12 months | ||
Secondary | Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM | Average duration: 12 months | ||
Secondary | Occurrence of spontaneous otorrhea | Average duration: 12 months | ||
Secondary | Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy | Average duration: 12 months | ||
Secondary | Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine. | Average duration: 12 months |
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