Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.
NCT00227214
Last updated date
ABOUT THIS STUDY
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.
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.
Pneumococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0-14
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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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Pneumococcal MeningitisStudy Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.
NCT00227214
- Alcalá de Henares,
- Alcorcón,
- Badalona,
- Barakaldo,
- Barcelona,
- Barco de Valdeorras,
- Bilbao,
- Boadilla del Monte,
- CEE,
- Esplugues de Llobregat,
- Estella,
- Ferrol,
- Figueres,
- Getafe,
- Girona,
- Granollers,
- La Coruña,
- Leganés,
- Lleida,
- Lugo,
- Madrid,
- Mondragón,
- Monforte de Lemos,
- Móstoles,
- Ourense,
- Pamplona,
- Pontevedra,
- Reus,
- Ribeira,
- Sabadell,
- San Lorenzo de El Escorial,
- San Sebastián,
- Tarragona,
- Terrasa,
- Tudela,
- Verín,
- Vigo,
- Vitoria,
- Zumárraga,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | June 2010 | |||