Clinical trial NCT01072227: Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Otitis Media
Keywords: Non-typeable Haemophilus Influenzae
Acute Otitis Media
Streptococcus Pneumoniae
Etiology
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged \>= 3 months and \< 5 years of age, diagnosed as having AOM in hospital by pediatricians or ear nose and throat (ENT) specialists.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
timeFrame: Average duration: 12 months
Secondary outcomes:
measure: Distribution of H. influenzae and S. pneumoniae serotypes.
timeFrame: Average duration: 12 months
measure: Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis
timeFrame: Average duration: 12 months
measure: Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM
timeFrame: Average duration: 12 months
measure: Occurrence of spontaneous otorrhea
timeFrame: Average duration: 12 months
measure: Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy
timeFrame: Average duration: 12 months
measure: Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.
timeFrame: Average duration: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan Hsien
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: