Study of Febrile Illness for Dengue-Endemic Areas in Latin America
NCT ID: NCT01293331
Last Updated: 2015-06-17
Study Results
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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COMPLETED
3000 participants
OBSERVATIONAL
2010-08-31
2012-04-30
Brief Summary
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Primary objectives:
* To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
* To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.
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Detailed Description
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No vaccine will be provided or administered in this study
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Cohort (Case )
Participants will be examined for fever in dengue endemic regions
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant in good health, based on medical history and physical examination
* Assent form has been signed and dated by the participant (if required by local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by the participant and/or an independent witness if required by local regulations)
* Participant able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria
* Planned participation in another clinical trial during the present study period
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
* Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with study procedures
* Receipt of blood or blood-derived products in the past 3 months
* Receipt of any vaccine in the 4 weeks preceding the day of enrollment except for pandemic influenza vaccination, which may be received at least 2 weeks before enrollment
* Planned receipt of any vaccine in the 4 weeks following enrollment
* Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
9 Years
16 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Regional Director
Role: STUDY_DIRECTOR
Sanofi Pasteur SA.
Locations
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Campo Grande, , Brazil
Goiânia, , Brazil
Natal-RN, , Brazil
Vitória, , Brazil
Acacias Meta, , Colombia
Aguazul (Casanare), , Colombia
Bogotá, , Colombia
Calarco (Quindio), , Colombia
Girardot (Cundinamarca), , Colombia
La Tebaida (Quindio), , Colombia
Montenegro (Quindio), , Colombia
Yopal (Casanare), , Colombia
Minatitlán, Veracruz Mexico, Mexico
Veracruz, Veracruz Mexico, Mexico
Municipio de Cd. Mante Tamaulipas, , Mexico
Quintana Roo, , Mexico
Guayama, Puerto Rico, Puerto Rico
San Juan, Puerto Rico, Puerto Rico
Countries
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References
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Dayan G, Arredondo JL, Carrasquilla G, Deseda CC, Dietze R, Luz K, Costa MSN, Cunha RV, Rey LC, Morales J, Reynales H, Miranda M, Zambrano B, Rivas E, Garbes P, Noriega F. Prospective cohort study with active surveillance for fever in four dengue endemic countries in Latin America. Am J Trop Med Hyg. 2015 Jul;93(1):18-23. doi: 10.4269/ajtmh.13-0663. Epub 2015 May 26.
Related Links
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Related Info
Other Identifiers
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U1111-1112-8481
Identifier Type: OTHER
Identifier Source: secondary_id
CYD35
Identifier Type: -
Identifier Source: org_study_id
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