Costa Rica Epidemiological Study on S. Pneumoniae

NCT01308827 | Suspended

• 1 other identifier: IAP-036
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Children 28 days to 36 months of age with suspected pneumococcal disease

Outcome Measures

Primary Outcomes (1)

• Impact of PCV 7 and PCV 13 on invasive pneumococcal disease in Costa Rican Children

  24 months

Secondary Outcomes (5)

• Describe serotype distribution, antimicrobial susceptibility, neurological sequelae in children with meningitis and describe bacteriology other than S. pneumoniae

  30 months

• Describe the antibiotic resistant rates of invasive S. pneumoniae isolates

  24 months

• Describe the serotype distribution of resistant S. pneumoniae isolates

  24 months

• Assess the neurologic sequelae of pneumococcal meningitis

  30 months

• Describe the bacteriology other than S. pneumoniae

  24 months

Study Arms (1)

Children with suspected pneumococcal invasive disease

Procedure: Blood culture; Procedure: Other cultures per Clinical routine practice

Interventions

Blood culture PROCEDURE

A baseline blood culture will be obtained in all participants

Children with suspected pneumococcal invasive disease

Other cultures per Clinical routine practice PROCEDURE

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

Children with suspected pneumococcal invasive disease

Eligibility Criteria

• Age: 28 Days - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Children 28 days to 36 months of age
• 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
• Subject belongs to the country specific target population for this study
• Informed consent obtained from parent(s) or legal guardian(s) -

You may not qualify if:

• Children younger than 28 days or older than 36 months of age at enrollment
• Children suspected of having dengue fever as determined by local standard of care(i.e., platelet count, tourniquet test) -

Sponsors & Collaborators

• Instituto de Atención Pediátrica: lead
• Ben-Gurion University of the Negev: collaborator
• Pfizer: collaborator

Study Sites (5)

Clinica Santa Catalina

Desamparados, Provincia de San José, Costa Rica

Location

Hospital CIMA San Jose

Escazú, Provincia de San José, Costa Rica

Location

Instituto de Atencion Pediatrica

San José, Provincia de San José, 607-1108, Costa Rica

Location

Hospital Clinica Biblica

San José, Provincia de San José, Costa Rica

Location

Hospital Metropolitano

San José, Provincia de San José, Costa Rica

Location

Biospecimen

Bacterial isolates

MeSH Terms

Interventions

Blood Culture

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Arturo Abdelnour, MD

  Instituto de Atencion Pediatrica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 4, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

CO (5)