Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
Main inclusion criteria:
- Children >= 2 months and =
- Spontaneous draining AOM =
exclusion criteria:
- Previous operation of the ear
- Chronic otitis media or tube placement with drainage >= 3 days
- Chronic disease/immune deficiency
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 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:
| |||
| 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 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
