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Trial record 1 of 1 for:    CYD35
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Study of Febrile Illness for Dengue-Endemic Areas in Latin America

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ClinicalTrials.gov Identifier: NCT01293331
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date February 9, 2011
First Posted Date February 10, 2011
Last Update Posted Date June 17, 2015
Study Start Date August 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2011)
  • Identification of acute febrile episodes in the cohort [ Time Frame: Up to 18 months after study entry ]
  • Detection of confirmed or probable dengue infection in the cohort [ Time Frame: Up to 18 months after study entry ]
Original Primary Outcome Measures
 (submitted: February 9, 2011)
Identification of acute febrile episodes and detection of confirmed or probable dengue infection in the cohort [ Time Frame: Up to 18 months after study entry ]
Change History Complete list of historical versions of study NCT01293331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Febrile Illness for Dengue-Endemic Areas in Latin America
Official Title Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Latin America
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants aged 9 to 16 years in 4 countries in Latin America: Brazil, Mexico, Colombia and Puerto Rico
Condition
  • Dengue Fever
  • Fever
Intervention Not Provided
Study Groups/Cohorts Study Cohort (Case )
Participants will be examined for fever in dengue endemic regions
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2012)
3000
Original Estimated Enrollment
 (submitted: February 9, 2011)
2500
Actual Study Completion Date April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Years to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Colombia,   Mexico,   Puerto Rico
Removed Location Countries Venezuela
 
Administrative Information
NCT Number NCT01293331
Other Study ID Numbers CYD35
U1111-1112-8481 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanofi
Study Sponsor Sanofi
Collaborators Not Provided
Investigators
Study Director: Regional Director Sanofi Pasteur SA.
PRS Account Sanofi
Verification Date June 2015