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Colombia Epidemiologic Surveillance Study (LEAP II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428051
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 29, 2007
Last Update Posted : October 27, 2011
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Pneumonia Meningitis Bacteremia Sepsis Other: Surveillance

Detailed 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.

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Study Type : Observational
Actual Enrollment : 32867 participants
Time Perspective: Prospective
Official Title: Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease
Study Start Date : September 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
All eligible patients Other: Surveillance
No study drug, only interventions are blood draws and Chest X-rays

Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428051

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Pfizer Investigational Site
Goiania, Goias, Brazil, 074065-050
Pfizer Investigational Site
Bogota, Colombia
Costa Rica
Pfizer Investigational Site
La Uruca, San Jose, Costa Rica, 607-1159
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT00428051     History of Changes
Other Study ID Numbers: 0887X1-900
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011

Keywords provided by Pfizer:
Streptococcal Pneumonia

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes