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Colombia Epidemiologic Surveillance Study

NCT ID: NCT00428051

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

32867 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Pneumonia Meningitis Bacteremia Sepsis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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All eligible patients

Surveillance

Intervention Type OTHER

No study drug, only interventions are blood draws and Chest X-rays

Interventions

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Surveillance

No study drug, only interventions are blood draws and Chest X-rays

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Goiânia, Goiás, Brazil

Site Status

Pfizer Investigational Site

Bogotá, , Colombia

Site Status

Pfizer Investigational Site

Uruca, Provincia de San José, Costa Rica

Site Status

Countries

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Brazil Colombia Costa Rica

References

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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 Bogota, Colombia. Vaccine. 2012 Aug 31;30(40):5886-92. doi: 10.1016/j.vaccine.2012.03.054. Epub 2012 Apr 4.

Reference Type DERIVED
PMID: 22484295 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-900&StudyName=Colombia%20Epidemiologic%20Surveillance%20Study

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1841004

Identifier Type: -

Identifier Source: secondary_id

0887X1-900

Identifier Type: -

Identifier Source: org_study_id