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

GlaxoSmithKline (GSK)

Status: Terminated

Conditions: Acute Otitis Media

Treatments: Procedure: Sample Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01072227

113932

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Single Group

Treatment:

Procedure: Sample Collection