Costa Rica Epidemiological Study on S. Pneumoniae
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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 |
- Impact of PCV 7 and PCV 13 on invasive pneumococcal disease in Costa Rican Children [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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: | September 2013 |
| Primary Completion Date: | March 2013 (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 |
Costa Rican children aged 28 days to 36 months of age with suspected pneumococcal invasive disease
Inclusion Criteria:
- 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) -
Exclusion Criteria:
- 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) -
Contacts and Locations| Contact: Arturo Abdelnour, MD | 00-506-2222-9234 ext 107 | aabdelnour@iped.net |
| Contact: Catalina Ulloa, MSC | 00-506-2222-9234 ext 110 | aabdelnour@iped.net |
| Costa Rica | |
| Clinica Santa Catalina | Recruiting |
| Desamparados, San Jose, Costa Rica | |
| Contact: Arturo Abdelnour, MD 00-506-2222-9234 ext 107 aabdelnour@iped.net | |
| Contact: Elias Jimenez, MD 00-506-2222-9234 drelias.jimenez@gmail.com | |
| Hospital CIMA San Jose | Recruiting |
| Escazu, San Jose, Costa Rica | |
| Contact: Arturo Abdelnour, MD 00-506-2222-9234 ext 107 aabdelnour@iped.net | |
| Contact: Elias Jimenez, MD 00-506-2208-1610 ext 110 drelias.jimenez@gmail.com | |
| Instituto de Atencion Pediatrica | Recruiting |
| San Jose, Costa Rica, 607-1108 | |
| Contact: Arturo Abdelnour, MD 00-506-2222-9234 ext 107 aabdelnour@iped.net | |
| Contact: Elias Jimenez, MD 00-506-2222-9234 drelias.jimenez@gmail.com | |
| Principal Investigator: Arturo Abdelnour, MD | |
| Sub-Investigator: Elias Jimenez, MD | |
| Hospital Clinica Biblica | Recruiting |
| San Jose, Costa Rica | |
| Contact: Arturo Abdelnour, MD 00-506-2222-9234 ext 107 aabdelnour@iped.net | |
| Contact: Elias Jimenez, MD 00-506-2222-9234 drelias.jimenez@gmail.com | |
| Hospital Metropolitano | Recruiting |
| San Jose, Costa Rica | |
| Contact: Arturo Abdelnour, MD 00-506-2222-9234 ext 107 aabdelnour@iped.net | |
| Contact: Elias Jimenez, MD 00-506-2222-9234 drelias.jimenez@gmail.com | |
| 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: | April 2, 2013 |
| 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 May 23, 2013