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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 : Terminated (The study was terminated for logistic reasons)
First Posted : February 22, 2010
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Acute Otitis Media Procedure: Sample Collection

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan
Study Start Date : July 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Single Group Procedure: Sample Collection

Outcome Measures

Primary Outcome Measures :
  1. Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens [ Time Frame: Average duration: 12 months ]

Secondary Outcome Measures :
  1. Distribution of H. influenzae and S. pneumoniae serotypes. [ Time Frame: Average duration: 12 months ]
  2. Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis [ Time Frame: Average duration: 12 months ]
  3. Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM [ Time Frame: Average duration: 12 months ]
  4. Occurrence of spontaneous otorrhea [ Time Frame: Average duration: 12 months ]
  5. Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy [ Time Frame: Average duration: 12 months ]
  6. Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine. [ Time Frame: Average duration: 12 months ]

Biospecimen Retention:   Samples With DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects aged >= 3 months and < 5 years of age, diagnosed as having AOM in hospital by pediatricians or ear nose and throat (ENT) specialists.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072227

GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taoyuan Hsien, Taiwan
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01072227     History of Changes
Other Study ID Numbers: 113932
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
Non-typeable Haemophilus Influenzae
Acute Otitis Media
Streptococcus Pneumoniae

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases