Colombia Epidemiologic Surveillance Study

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NCT00428051

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Study Location
Pfizer Investigational Site
Goiania, Goias, 074065-050, Brazil
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Contact
1-800-718-1021
[email protected]
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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

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Pneumonia, Meningitis, Bacteremia, SepsisColombia Epidemiologic Surveillance Study
NCT00428051
  1. Goiania, Goias
  2. Bogota,
  3. La Uruca, San Jose
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Colombia Epidemiologic Surveillance Study
Official Title Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease
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.
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates
Sampling Method Probability Sample
Study Population Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria
Condition
  • Pneumonia
  • Meningitis
  • Bacteremia
  • Sepsis
Intervention Other: Surveillance
No study drug, only interventions are blood draws and Chest X-rays
Study Groups/Cohorts All eligible patients
Intervention: Other: Surveillance
Publications * 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.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 26, 2011)		32867
Original Enrollment Not Provided
Actual Study Completion Date October 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages up to 36 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Colombia,   Costa Rica
Removed Location Countries Mexico
 
Administrative Information
NCT Number NCT00428051
Other Study ID Numbers 0887X1-900
B1841004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011