Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.

NCT00227214

Last updated date
Study Location
Alcalá de Henares, , , Spain
Contact
1-800-718-1021

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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
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
  1. Alcalá de Henares,
  2. Alcorcón,
  3. Badalona,
  4. Barakaldo,
  5. Barcelona,
  6. Barco de Valdeorras,
  7. Bilbao,
  8. Boadilla del Monte,
  9. CEE,
  10. Esplugues de Llobregat,
  11. Estella,
  12. Ferrol,
  13. Figueres,
  14. Getafe,
  15. Girona,
  16. Granollers,
  17. La Coruña,
  18. Leganés,
  19. Lleida,
  20. Lugo,
  21. Madrid,
  22. Mondragón,
  23. Monforte de Lemos,
  24. Móstoles,
  25. Ourense,
  26. Pamplona,
  27. Pontevedra,
  28. Reus,
  29. Ribeira,
  30. Sabadell,
  31. San Lorenzo de El Escorial,
  32. San Sebastián,
  33. Tarragona,
  34. Terrasa,
  35. Tudela,
  36. Verín,
  37. Vigo,
  38. Vitoria,
  39. 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
 (submitted: June 24, 2010)
160
Original Enrollment
 (submitted: September 22, 2005)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2010