Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan

GlaxoSmithKline1 site in 1 country10 target enrollmentJuly 2010

ConditionsAcute Otitis Media

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Otitis Media
Sponsor: GlaxoSmithKline
Enrollment: 10
Locations: 1
Primary Endpoint: Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

April 2011

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens

Time Frame: Average duration: 12 months

Secondary Outcomes

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)
Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.(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 with treatment failure and in new AOM cases without treatment therapy(Average duration: 12 months)