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Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Last updated on November 21, 2019

FOR MORE INFORMATION
Study Location
Dr. Andreas Busse
Tegernsee, Bavarian, 83684 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Otitis Media
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-5 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Main inclusion criteria:

- Children >= 2 months and =

- Spontaneous draining AOM =

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

exclusion criteria:

- Previous operation of the ear

- Chronic otitis media or tube placement with drainage >= 3 days

- Chronic disease/immune deficiency

NCT00768534
Pfizer
Completed
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

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Descriptive Information
Brief TitleStudy Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Official TitleMicrobiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
Brief SummaryDescribe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Middle ear fluid and anasopharyngeal swab
Sampling MethodNon-Probability Sample
Study Populationcommunity sample
ConditionOtitis Media
InterventionNot Provided
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: October 5, 2016)
2138
Original Estimated Enrollment
 (submitted: October 7, 2008)
1000
Actual Study Completion DateOctober 2015
Actual Primary Completion DateOctober 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages2 Months to 5 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00768534
Other Study ID Numbers0887X1-4454
B1841014 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now