Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
NCT00768534
ABOUT THIS STUDY
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1-800-718-1021
Main inclusion criteria:
- Children >= 2 months and =< 5 years
- Spontaneous draining AOM =< 2 days Main
exclusion criteria:
- Previous operation of the ear
- Chronic otitis media or tube placement with drainage >= 3 days
- Chronic disease/immune deficiency
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Descriptive Information | ||||
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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 | 2138 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria: exclusion criteria:
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Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2016 |