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

NCT01072227 | Terminated

• 1 other identifier: 113932
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

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

Conditions

Acute Otitis Media

Keywords

Non-typeable Haemophilus Influenzae; Acute Otitis Media; Streptococcus Pneumoniae; Etiology

Outcome Measures

Primary Outcomes (1)

• Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens

  Average duration: 12 months

Secondary Outcomes (6)

• Distribution of H. influenzae and S. pneumoniae serotypes.

  Average duration: 12 months

• Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis

  Average duration: 12 months

• Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM

  Average duration: 12 months

• Occurrence of spontaneous otorrhea

  Average duration: 12 months

• Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy

  Average duration: 12 months

Study Arms (1)

Single Group

Procedure: Sample Collection

Interventions

Sample Collection PROCEDURE

Tissue

Single Group

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Taipei, Taiwan

Location

GSK Investigational Site

Taoyuan Hsien, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Otitis Media

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

TW (2)