Last updated: 11/03/2018 15:51:22
Study to Identify and characterize the bacteria causing Acute Otitis Media episodes in young children in Taiwan
GSK study ID
113932
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Identification and characterization of the bacteria causing Acute Otitis Media (AOM) episodes in young children in Taiwan
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
Timeframe: Average duration: 12 months
Secondary outcomes:
Distribution of H. influenzae and S. pneumoniae serotypes.
Timeframe: Average duration: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis
Timeframe: Average duration: 12 months
Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM
Timeframe: Average duration: 12 months
Occurrence of spontaneous otorrhea
Timeframe: Average duration: 12 months
Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy
Timeframe: Average duration: 12 months
Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.
Timeframe: Average duration: 12 months
Interventions:
Enrollment:
10
Primary completion date:
2011-20-04
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Acute otitis media
Product
GSK2647154A
Collaborators
Not applicable
Study date(s)
July 2010 to April 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
3 months - 5 years
Accepts healthy volunteers
No
- 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:
- Hospitalized during the diagnosis of acute otitis media.
- Onset of otorrhea greater than 1 day prior to enrolment.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
Hospitalized during the diagnosis of acute otitis media.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
2011-20-04
Actual study completion date
2011-20-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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