Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
NCT00768534
Last updated date
ABOUT THIS STUDY
Describe the patient population and bacterial microbiology of pediatric patients presenting
with spontaneous draining acute otitis media
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
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
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 =< 5 years
- Spontaneous draining AOM =< 2 days Main
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
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Advanced Information
| 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 | |||