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

May 25, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • GSK Investigational Site
      • Taoyuan Hsien, Taiwan
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Group
Procedure: Sample Collection
Tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
Time Frame: Average duration: 12 months
Average duration: 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113932

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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