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Colombia Epidemiologic Surveillance Study

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NCT00428051

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Goiania, Goias, 074065-050 Brazil
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia, Meningitis, Bacteremia, Sepsis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-36
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00428051
Pfizer
Terminated
Colombia Epidemiologic Surveillance Study

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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. doi: 10.1016/j.vaccine.2012.03.054. 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
Sexes Eligible for Study: All
up to 36 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Colombia,   Costa Rica
Mexico
 
NCT00428051
0887X1-900
B1841004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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