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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01293331

Collaborator

(none)

3,000

Enrollment

Locations

Duration (Months)

166.7

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dengue Fever Fever

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Latin America

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Study Cohort (Case ) Participants will be examined for fever in dengue endemic regions

Outcome Measures

Primary Outcome Measures

Identification of acute febrile episodes in the cohort [Up to 18 months after study entry]
Detection of confirmed or probable dengue infection in the cohort [Up to 18 months after study entry]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Campo Grande		Brazil	79074460
2	Goiania		Brazil	74675-020
3	Natal-RN		Brazil	59025-600
4	Vitoria		Brazil	29040-091
5	Acacias Meta		Colombia
6	Aguazul (Casanare)		Colombia
7	Bogota		Colombia
8	Calarco (Quindio)		Colombia
9	Girardot (Cundinamarca)		Colombia
10	La Tebaida (Quindio)		Colombia
11	Montenegro (Quindio)		Colombia
12	Yopal (Casanare)		Colombia
13	Minatitlan	Veracruz Mexico	Mexico	96760
14	Veracruz	Veracruz Mexico	Mexico	91900
15	Municipio de Cd. Mante Tamaulipas		Mexico
16	Quintana Roo.		Mexico
17	Guayama		Puerto Rico	00784
18	San Juan		Puerto Rico	00918