Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan

NCT ID: NCT01072227

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-04-30

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

Conditions

Acute Otitis Media

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Group

Sample Collection

Intervention Type: PROCEDURE

Tissue

Interventions

Sample Collection

Tissue

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan Hsien, , Taiwan

Countries

Taiwan

Other Identifiers

113932

Identifier Type: -

Identifier Source: org_study_id