Study Evaluating Microbiological Analysis of Spontaneous... | NCT00768534

Studies
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

NCT00768534

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 6, 2016Estimated

Enrollment

2,138Actual

Phase

Not provided

Conditions

Otitis Media

Interventions

Not provided

Countries

Germany

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

ID	Type	Description	Link
B1841014	Other Identifier	Alias Study Number

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

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

Oct 5, 2016

Last Update Posted Date

Oct 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

Detailed Description

Not provided

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

2,138Actual

Measure	Description	Time Frame
serotype distribution		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Main inclusion criteria:

Children >= 2 months and =< 5 years
Spontaneous draining AOM =< 2 days Main

Exclusion Criteria:

exclusion criteria:

Previous operation of the ear
Chronic otitis media or tube placement with drainage >= 3 days
Chronic disease/immune deficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Andreas Busse		Tegernsee	Bavarian	83684	Germany

References Module

Citations

Not provided

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases