Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.
NCT00227214
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- All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.
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Descriptive Information | ||||
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Brief Title | Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar. | |||
Official Title | Prevalence of Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar. | |||
Brief Summary | The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar. Also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Children from 0 up to 14 years of age with a diagnosis of confirmed or probable pneumococcal meningitis or with a diagnosis of suspected bacterial meningitis without bacterial or viral isolation. | |||
Condition | Pneumococcal Meningitis | |||
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 | 160 | |||
Original Enrollment | 500 | |||
Actual Study Completion Date | December 2006 | |||
Actual Primary Completion Date | December 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | up to 14 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00227214 | |||
Other Study ID Numbers | 0887X-101539 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | June 2010 |