NCT00768534

Completed

Study Evaluating Microbiological Analysis of Spontaneous Dra...

Pfizer Source

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Other study identifiers

Sponsor study identifier

0887X1-4454

Secondary identifiers

B1841014

OTHER · Alias Study Number

Study Type

observational

Actual enrollment (reported)

2,138

Locations

1 country

Sites

1

Timeline

Study Start

October 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2015

Actual (reported)

Study Completion

October 2015

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 2,138 participants
Study completion date: October 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 7, 2008
Actual (reported)
First Posted
October 8, 2008
Actual (reported)
Primary Completion
October 2015
Actual (reported)
Study Completion
October 2015
Actual (reported)

Last Updated: October 6, 2016
Status Verified: October 2016
Last Update Submitted: 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

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (1)

Dr. Andreas Busse

Tegernsee, Bavarian, 83684, Germany

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

Enrollment

2,138 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableTerminated

NCT00781521

Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

Phase 3Completed

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.

Primary Completion

October 2015

Actual (reported)

Study Completion

October 2015

Actual (reported)

Last Updated

October 6, 2016

Record last verified: 2016-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00768534
Data provider: ClinicalTrials.gov
Source updated: 2016-10-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:37 UTC

Locations

DE(1)

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations