Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan
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ClinicalTrials.gov Identifier: NCT01072227
Recruitment Status :
(The study was terminated for logistic reasons)
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Ages Eligible for Study:
3 Months to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects aged >= 3 months and < 5 years of age, diagnosed as having AOM in hospital by pediatricians or ear nose and throat (ENT) specialists.
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.
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.