NCT00768534

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,138

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

7 years

First QC Date

October 7, 2008

Last Update Submit

October 5, 2016

Conditions

Otitis Media

Keywords

Acute Otitis MediaSerotype distribution

Outcome Measures

Primary Outcomes (1)

  • serotype distribution

    30 days

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Andreas Busse

Tegernsee, Bavarian, 83684, Germany

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Middle ear fluid and anasopharyngeal swab

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

DE(1)