Costa Rica Epidemiological Study on S. Pneumoniae

This study has suspended participant recruitment.
(Study recruitment was suspended due to lack of funding)
Sponsor:
Collaborators:
Ben-Gurion University of the Negev
Pfizer
Information provided by (Responsible Party):
Instituto de Atención Pediátrica
ClinicalTrials.gov Identifier:
NCT01308827
First received: February 25, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Streptococcus Pneumoniae
Procedure: Blood culture
Procedure: Other cultures per Clinical routine practice

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuation of the Costa Rican Epidemiologic Surveillance for Invasive Pneumococcal Disease After Introduction of the Seven Valent Vaccine Into the Universal Vaccination Program

Resource links provided by NLM:


Further study details as provided by Instituto de Atención Pediátrica:

Primary Outcome Measures:
  • Impact of PCV 7 and PCV 13 on invasive pneumococcal disease in Costa Rican Children [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe serotype distribution, antimicrobial susceptibility, neurological sequelae in children with meningitis and describe bacteriology other than S. pneumoniae [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Describe the antibiotic resistant rates of invasive S. pneumoniae isolates [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Describe the serotype distribution of resistant S. pneumoniae isolates [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assess the neurologic sequelae of pneumococcal meningitis [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Describe the bacteriology other than S. pneumoniae [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Description:

Bacterial isolates


Estimated Enrollment: 4000
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children with suspected pneumococcal invasive disease 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Costa Rican children aged 28 days to 36 months of age with suspected pneumococcal invasive disease

Criteria

Inclusion Criteria:

  1. Children 28 days to 36 months of age
  2. Presenting to or referred to a participating healthcare facility with a measured temperature of ≥39.0 °C within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, sepsis, or other invasive pneumococcal disease, regardless of temperature
  3. Subject belongs to the country specific target population for this study
  4. Informed consent obtained from parent(s) or legal guardian(s) -

Exclusion Criteria:

  1. Children younger than 28 days or older than 36 months of age at enrollment
  2. Children suspected of having dengue fever as determined by local standard of care(i.e., platelet count, tourniquet test) -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308827

Locations
Costa Rica
Clinica Santa Catalina
Desamparados, San Jose, Costa Rica
Hospital CIMA San Jose
Escazu, San Jose, Costa Rica
Instituto de Atencion Pediatrica
San Jose, Costa Rica, 607-1108
Hospital Clinica Biblica
San Jose, Costa Rica
Hospital Metropolitano
San Jose, Costa Rica
Sponsors and Collaborators
Instituto de Atención Pediátrica
Ben-Gurion University of the Negev
Pfizer
Investigators
Principal Investigator: Arturo Abdelnour, MD Instituto de Atencion Pediatrica
  More Information

No publications provided

Responsible Party: Instituto de Atención Pediátrica
ClinicalTrials.gov Identifier: NCT01308827     History of Changes
Other Study ID Numbers: IAP-036, IAP-036
Study First Received: February 25, 2011
Last Updated: March 24, 2014
Health Authority: Costa Rica Ethics Comittee: Universidad de Ciencias Medicas, San Jose, Costa Rica

Keywords provided by Instituto de Atención Pediátrica:
Children 28 days to 36 months of age with suspected pneumococcal disease

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 31, 2014