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

Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01072227
• Other study ID #: 113932
• Status: Terminated
• Phase: N/A
• First received: February 18, 2010
• Last updated: May 25, 2017
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Procedure:
• Sample Collection
Tissue

Locations

Country	Name	City	State
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan Hsien

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens		Average duration: 12 months
Secondary	Distribution of H. influenzae and S. pneumoniae serotypes.		Average duration: 12 months
Secondary	Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis		Average duration: 12 months
Secondary	Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM		Average duration: 12 months
Secondary	Occurrence of spontaneous otorrhea		Average duration: 12 months
Secondary	Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy		Average duration: 12 months
Secondary	Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.		Average duration: 12 months