Colombia Epidemiologic Surveillance Study (LEAP II)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00428051
First received: January 25, 2007
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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 Intervention
Pneumonia
Meningitis
Bacteremia
Sepsis
Other: Surveillance

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates


Enrollment: 32867
Study Start Date: September 2006
Study Completion Date: October 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All eligible patients Other: Surveillance
No study drug, only interventions are blood draws and Chest X-rays

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.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
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

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
  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: NCT00428051

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

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00428051     History of Changes
Other Study ID Numbers: 0887X1-900, B1841004
Study First Received: January 25, 2007
Last Updated: October 26, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Pfizer:
Epidemiology
Surveillance
Streptococcal Pneumonia

Additional relevant MeSH terms:
Bacteremia
Meningitis
Pneumonia
Sepsis
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 26, 2014