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Costa Rica Epidemiological Study on S. Pneumoniae

NCT01308827 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2014-03-26

No results posted yet for this study

Summary

Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia and pneumococcal meningitis among infants and children worldwide. Knowledge of the epidemiology of pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease usefulness of pneumococcal conjugate immunization. There is a paucity of information regarding pneumococcal disease burden in children in Latin America. Most studies are based on passive microbiology laboratory surveillance that does not capture all invasive disease, thus underestimating the true disease burden. Data from an active surveillance is available from an specific region in Costa Rica, before introduction of universal vaccination with PCV-7. On January 2009, PCV-7 was introduce into the universal vaccination program for all children born after or on September 2008 using a 3+1 regimen therefore there is a possibility to analyze the benefits of the introduction of this vaccine into the universal immunization program. The only effectiveness data from Latin America have been published from Uruguay where a significant decline in the incidence of pneumonias and meningitis was observed following the introduction of PCV-7. This was associated with an increment of serotypes 19A, 1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011, PCV-7 was changed for PCV 13. This study will provide information regarding the impact of PCV-7 and PCV-13.

Conditions

  • Streptococcus Pneumoniae

Interventions

PROCEDURE

Blood culture

A baseline blood culture will be obtained in all participants

PROCEDURE

Other cultures per Clinical routine practice

Cultures from other sterile sites will be obtained per routine clinical practice

Sponsors & Collaborators

  • Ben-Gurion University of the Negev

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Instituto de Atención Pediátrica

    lead OTHER

Principal Investigators

  • Arturo Abdelnour, MD · Instituto de Atencion Pediatrica

Eligibility

Min Age
28 Days
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Costa Rica

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308827 on ClinicalTrials.gov