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NCT00428051 Clinical Trial

Colombia Epidemiologic Surveillance Study

Sepsis Clinical Trial

— LEAP II  

Official title:
Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00428051
Other study ID # 0887X1-900
Secondary ID B1841004
Status Terminated
Phase N/A
First received January 25, 2007
Last updated October 26, 2011
Start date September 2006
Est. completion date October 2011

Study information
Verified date October 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Study type Observational

Clinical Trial Summary

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

Description:

The study was stopped based on a decision to include PCV 10 in the National Immunization Program in Colombia. The study was designed to measure the impact of PCV 7 and 13 and is no longer feasible.

Recruitment information / eligibility
Status Terminated
Enrollment 32867
Est. completion date October 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 36 Months
Eligibility Inclusion Criteria:

- Children 28 days to 36 months of age

- Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease

Exclusion Criteria:

- Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Surveillance
No study drug, only interventions are blood draws and Chest X-rays

Locations
Country Name City State
Brazil Pfizer Investigational Site Goiania Goias
Colombia Pfizer Investigational Site Bogota
Costa Rica Pfizer Investigational Site La Uruca San Jose

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Brazil,  Colombia,  Costa Rica, 

Outcome
Type Measure Description Time frame Safety issue
Primary Annual age specific incidence rate of invasive pneumococcal disease based on the number of identified cases from the study sites and the size of the population at risk for children 28 days to 36 months of age 2 years No
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