Study to Identify and Characterize the Bacteria Causing A... | NCT01072227

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

NCT01072227

Sponsor

GlaxoSmithKline

Status

Terminated

Last Update Posted

May 30, 2017Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Acute Otitis Media

Interventions

Sample Collection

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated for logistic reasons

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Label	Type	Description	Intervention Names
Single Group			Procedure: Sample Collection

Name	Type	Description	Arm Group Labels	Other Names
Sample Collection	Procedure	Tissue	Single Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

5 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Taipei			Taiwan
GSK Investigational Site

ID	Term
D010033	Otitis Media

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D013048	Specimen Handling

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided