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Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

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NCT00768534

Last updated on March 24, 2020
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FOR MORE INFORMATION
Study Location
Dr. Andreas Busse
Tegernsee, Bavarian, 83684 Germany
See other locations
Contact
1-800-718-1021
[email protected]
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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 Title Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Official Title Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
Brief Summary Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Middle ear fluid and anasopharyngeal swab
Sampling Method Non-Probability Sample
Study Population community sample
Condition Otitis Media
Intervention Not Provided
Study Groups/Cohorts Not 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 Status Completed
Actual Enrollment
 (submitted: October 5, 2016) 		2138
Original Estimated Enrollment
 (submitted: October 7, 2008) 		1000
Actual Study Completion Date October 2015
Actual Primary Completion Date October 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
Ages 2 Months to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00768534
Other Study ID Numbers 0887X1-4454
B1841014 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 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]

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