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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
History of Changes

January 25, 2007
October 26, 2011
September 2006
February 2011   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00428051 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Colombia Epidemiologic Surveillance Study
Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease

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.

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates
Probability Sample

Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria
  • Pneumonia
  • Meningitis
  • Bacteremia
  • Sepsis
Other: Surveillance
No study drug, only interventions are blood draws and Chest X-rays
All eligible patients
Intervention: Other: Surveillance
Benavides JA, Ovalle OO, Salvador GR, Gray S, Isaacman D, Rodgers GL. Population-based surveillance for invasive pneumococcal disease and pneumonia in infants and young children in Bogotá, Colombia. Vaccine. 2012 Aug 31;30(40):5886-92. Epub 2012 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32867
October 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
up to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Colombia,   Costa Rica
 
NCT00428051
0887X1-900, B1841004
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP