Colombia Epidemiologic Surveillance Study

NCT00428051 | Terminated

• 2 other identifiers: 0887X1-900B1841004
• Study Type: observational
• Target: 32,867
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pneumonia; Meningitis; Bacteremia; Sepsis

Keywords

Epidemiology; Surveillance; Streptococcal Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

All eligible patients

Other: Surveillance

Interventions

Surveillance OTHER

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

All eligible patients

Eligibility Criteria

• Age: 28 Days - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Goiânia, Goiás, 074065-050, Brazil

Location

Pfizer Investigational Site

Bogotá, Colombia

Location

Pfizer Investigational Site

Uruca, Provincia de San José, 607-1159, Costa Rica

Location

Related Publications (1)

• 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.

  PMID: 22484295 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates

MeSH Terms

Conditions

Pneumonia; Meningitis; Bacteremia; Sepsis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Neuroinflammatory Diseases; Nervous System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: September 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

CO (1); BR (1)