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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293331
• Other study ID #: CYD35
• Secondary ID: U1111-1112-8481
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: June 16, 2015
• Start date: August 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosMexico: Ministry of HealthBrazil: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 16 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Fever

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Brazil,  Colombia,  Mexico,  Puerto Rico, 

References & Publications (1)

Dayan G, Arredondo JL, Carrasquilla G, Deseda CC, Dietze R, Luz K, Costa MS, 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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of acute febrile episodes in the cohort		Up to 18 months after study entry	No
Primary	Detection of confirmed or probable dengue infection in the cohort		Up to 18 months after study entry	No

External Links

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