Epidemiologic Surveillance of S. Pneumoniae - Full Text View

Epidemiologic Surveillance of S. Pneumoniae

This study is currently recruiting participants.
Verified by Wyeth, December 2007

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00428051

Purpose

To determine the incidence of invasive pneumococcal disease in Latin America

Condition	Intervention
Pneumococcal Disease	Procedure: Blood Culture

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Multinational Latin American Epidemiologic Surveillance for Invasive Pneumococcal Disease

Further study details as provided by Wyeth:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood cultures; Additional speciments from other sterile sites (e.g., pleural fluid, CSF, joint fluid) will be collected as per routine medical practice

Estimated Enrollment:	4000
Study Start Date:	September 2006
Estimated Study Completion Date:	April 2009

Groups/Cohorts	Assigned Interventions
1 Suspected Invasive Pneumococcal disease	Procedure: Blood Culture Blood cultures; Additional speciments from other sterile sites (e.g., pleural fluid, CSF, joint fluid) will be collected as per routine medical practice

Eligibility

Ages Eligible for Study:	up to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Children (ages 28 days to 36 months of age) with possible invasive pneumococcal disease

Criteria

Inclusion Criteria:

Children 28 days to 36 months of age
Presenting to or referred to a participating healthcare facility with a measured temperature of greater than or equal to 39.0º C within 24 hours prior to screening or with clinical suspicion of pneumonia, meningitis, sepsis, or other invasive pneumococcal disease, regardless of temperature
Subject belongs to the country specific target population for this study

Exclusion Criteria:

Any patient that based on the criteria of the treating physician should not participate in the study; examples: such as those with suspected dengue or urinary tract infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428051

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


Brazil
		Recruiting
	Goiania, Brazil, 74605-050

Colombia, DC
		Recruiting
	Bogota, DC, Colombia, 27-28

Costa Rica, San Jose
		Recruiting
	La Uruca, San Jose, Costa Rica, 1150

Mexico
		Active, not recruiting
	Durango, Mexico, 34000

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Clinical Trials Registry Specialist) )
Study ID Numbers:	0887X1-900
First Received:	January 25, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00428051
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Wyeth:

Fever

Invasive Infection

Invasive Pneumococcal Disease

Study placed in the following topic categories:

Fever

Pneumonia

ClinicalTrials.gov processed this record on October 03, 2008