NCT00227214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 28, 2010

Status Verified

June 1, 2010

Enrollment Period

2.9 years

First QC Date

September 12, 2005

Last Update Submit

June 24, 2010

Conditions

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Unknown Facility

A Coruña, Spain

Location

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Alcalá de Henares, Spain

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Alcorcón, Spain

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Arrasate / Mondragón, Spain

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Badalona, Spain

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Barakaldo, Spain

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Barcelona, Spain

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Barco de Valdeorras, Spain

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Bilbao, Spain

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Boadilla del Monte, Spain

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Cee, Spain

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El Escorial, Spain

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Esplugues de Llobregat, Spain

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Estella-Lizarra, Spain

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Ferrol, Spain

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Figueres, Spain

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Getafe, Spain

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Girona, Spain

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Granollers, Spain

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Leganés, Spain

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Lleida, Spain

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Lugo, Spain

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Madrid, Spain

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Monforte de Lemos, Spain

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Móstoles, Spain

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Ourense, Spain

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Pamplona, Spain

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Pontevedra, Spain

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Reus, Spain

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Ribeira, Spain

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Sabadell, Spain

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San Sebastián, Spain

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Tarragona, Spain

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Terrassa, Spain

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Tudela, Spain

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Verín, Spain

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Vigo, Spain

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Vitoria-Gasteiz, Spain

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Zumarraga, Spain

Location

MeSH Terms

Conditions

Meningitis, Pneumococcal

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 27, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 28, 2010

Record last verified: 2010-06

Locations