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

This study has been terminated.
(The study was terminated for logistic reasons)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01072227
First received: February 18, 2010
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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 Intervention
Acute Otitis Media
Procedure: Sample Collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of H. influenzae and S. pneumoniae serotypes. [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]
  • Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]
  • Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of spontaneous otorrhea [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine. [ Time Frame: Average duration: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue


Enrollment: 10
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single Group Procedure: Sample Collection
Tissue

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072227

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01072227     History of Changes
Other Study ID Numbers: 113932
Study First Received: February 18, 2010
Last Updated: May 12, 2011
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014