Study of Febrile Illness for Dengue-Endemic Areas in Latin America

NCT ID: NCT01293331

Last Updated: 2015-06-17

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

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to detect acute febrile episodes and dengue infection in five Latin American countries to assess dengue seroprevalence.

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.

Detailed Description

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All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.

No vaccine will be provided or administered in this study

Conditions

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Dengue Fever Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Aged 9 to 16 years on the day of inclusion and resident of the site zone
* 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

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment
* 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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Regional Director

Role: STUDY_DIRECTOR

Sanofi Pasteur SA.

Locations

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Campo Grande, , Brazil

Site Status

Goiânia, , Brazil

Site Status

Natal-RN, , Brazil

Site Status

Vitória, , Brazil

Site Status

Acacias Meta, , Colombia

Site Status

Aguazul (Casanare), , Colombia

Site Status

Bogotá, , Colombia

Site Status

Calarco (Quindio), , Colombia

Site Status

Girardot (Cundinamarca), , Colombia

Site Status

La Tebaida (Quindio), , Colombia

Site Status

Montenegro (Quindio), , Colombia

Site Status

Yopal (Casanare), , Colombia

Site Status

Minatitlán, Veracruz Mexico, Mexico

Site Status

Veracruz, Veracruz Mexico, Mexico

Site Status

Municipio de Cd. Mante Tamaulipas, , Mexico

Site Status

Quintana Roo, , Mexico

Site Status

Guayama, Puerto Rico, Puerto Rico

Site Status

San Juan, Puerto Rico, Puerto Rico

Site Status

Countries

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Brazil Colombia Mexico Puerto Rico

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.

Reference Type RESULT
PMID: 26013373 (View on PubMed)

Related Links

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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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