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Colombia Epidemiologic Surveillance Study

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Goiania, Goias, 074065-050 Brazil
Contact
1-800-718-1021
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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Descriptive Information
Brief TitleColombia Epidemiologic Surveillance Study
Official TitleMultinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease
Brief SummaryThe 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 DescriptionThe 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 TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples With DNA
Description:
Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates
Sampling MethodProbability Sample
Study PopulationEpidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria
Condition
  • Pneumonia
  • Meningitis
  • Bacteremia
  • Sepsis
InterventionOther: Surveillance
No study drug, only interventions are blood draws and Chest X-rays
Study Groups/CohortsAll 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 StatusTerminated
Actual Enrollment
 (submitted: October 26, 2011)
32867
Original EnrollmentNot Provided
Actual Study Completion DateOctober 2011
Actual Primary Completion DateFebruary 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
Agesup to 36 Months   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesBrazil,   Colombia,   Costa Rica
Removed Location CountriesMexico
 
Administrative Information
NCT NumberNCT00428051
Other Study ID Numbers0887X1-900
B1841004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2011

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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